Optetrak 200-01-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10885862039521), received between Feb 11, 2020 and Feb 14, 2020 — classified as 22 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 reports).

6 other recalls cover devices cleared under the same FDA submission (K932690); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK KNEE SYSTEM - CEMENTED CRUCIATE RETAINED (CR) FEMORAL COMPONENT - SIZE 2 (CATALOG 200-01-02, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/1T 2F/1T(CATALOG 200-04-21, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 2 - 13MM (CATALOG 200-22-13, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 32MM (CATALOG 200-02-32, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2011, APPROXIMATELY 22 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA. THE EXACTECH WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9711531 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS 63 Y/O (BMI=27), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2011, APPROXIMATELY 25 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE FEMUR AND TIBIA. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

  Patient problems: Failure of Implant

  MAUDE report 9711313 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O (BMI=30), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2008. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2010, APPROXIMATELY 22 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE PATELLA. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6) NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, IT IS KNOWN THAT DEVICE SPECIFIC RISKS CONSIST OF: FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURG

  Patient problems: Failure of Implant

  MAUDE report 9711117 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2015, APPROXIMATELY 86 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR AND TIBIA. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, IT IS KNOWN THAT DEVICE SPECIFIC RISKS CONSIST OF: FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFE

  Patient problems: Failure of Implant

  MAUDE report 9710114 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2015, APPROXIMATELY 93 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIA. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, IT IS KNOWN THAT DEVICE SPECIFIC RISKS CONSIST OF: FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT

  Patient problems: Failure of Implant

  MAUDE report 9710107 ↗
• InjuryFeb 13, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY ((B)(6)), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2005. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2012, APPROXIMATELY 84 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE PATELLA. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6) NATIONAL JOINT REGISTRY ((B)(6)); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, IT IS KNOWN THAT DEVICE SPECIFIC RISKS CONSIST OF: FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY

  Patient problems: Failure of Implant

  MAUDE report 9709856 ↗
• InjuryFeb 13, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2005. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2006, APPROXIMATELY 15 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIA. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, IT IS KNOWN THAT DEVICE SPECIFIC RISKS CONSIST OF: FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR POSTOPERATIVE PERIOD. REVISIONS OR SURGICAL INTERVENTIONS ARE

  Patient problems: Failure of Implant

  MAUDE report 9709832 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, (B)(6) CM, (B)(6) KG (BMI=29), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2010, APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: No Information

  MAUDE report 9709744 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY ((B)(6)), THIS (B)(6) Y/O, 147 CM, (B)(6) KG (BMI=41), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2013, APPROXIMATELY 47 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6) NATIONAL JOINT REGISTRY ((B)(6)); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THE PATIENT HAS A HIGH BMI WHICH INDICATES THAT THEY ARE OVERWEIGHT, THIS CAN INCREASE BIOMECHANICAL STRESSORS ON NATURAL AND ARTIFICIAL JOINTS. NO ADDITIONAL PATIENT MEDICAL HISTORY INFORMATION IS PROV

  Patient problems: No Information

  MAUDE report 9709328 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, 168 CM, (B)(6) KG (BMI=39), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2011, APPROXIMATELY 24 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THE PATIENT HAS A HIGH BMI WHICH INDICATES THAT THEY ARE OVERWEIGHT, THIS CAN INCREASE BIOMECHANICAL STRESSORS ON NATURAL AND ARTIFICIAL JOINTS. NO ADDITIONAL PATIENT MEDICAL HISTORY INFO

  Patient problems: No Information

  MAUDE report 9709188 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, 145 CM, (B)(6) KG (BMI=37), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2008. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2009, APPROXIMATELY 9 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THE PATIENT HAS A HIGH BMI WHICH INDICATES THAT THEY ARE OVERWEIGHT, THIS CAN INCREASE BIOMECHANICAL STRESSORS ON NATURAL AND ARTIFICIAL JOINTS. NO ADDITIONAL PATIENT MEDICAL HISTORY IN

  Patient problems: No Information

  MAUDE report 9708406 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), A (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE RIGHT KNEE ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2017, APPROXIMATELY 115 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Bacterial Infection

  MAUDE report 9707961 ↗
• InjuryFeb 13, 2020Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2008, APPROXIMATELY 13 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO COMPONENT DISSOCIATION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, IT IS KNOWN THAT DEVICE SPECIFIC RISKS CONSIST OF: FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. SURGICAL RISK INCLUDES PAIN. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT AD

  Patient problems: No Information

  MAUDE report 9706557 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2008, APPROXIMATELY 13 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO PAIN. THE UNDERLYING CAUSE FOR PAIN WAS NOT REPORTED. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Pain

  MAUDE report 9706384 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2008, APPROXIMATELY 14 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO PAIN. THE UNDERLYING CAUSE FOR PAIN WAS NOT REPORTED. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Pain

  MAUDE report 9706329 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY ((B)(6)), A (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE LEFT KNEE ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2008, APPROXIMATELY 13 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO DETACHMENT OF DEVICE OR DEVICE COMPONENT (COMPONENT DISSOCIATION). FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6) NATIONAL JOINT REGISTRY ((B)(6)); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Failure of Implant

  MAUDE report 9703634 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2006. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2008, APPROXIMATELY 31 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR),, THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: No Information

  MAUDE report 9703599 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), A (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE ON (B)(6) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2009, APPROXIMATELY 22 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Failure of Implant

  MAUDE report 9703565 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, 149 CM, (B)(6) (BMI=36), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT ON (B)(6) 2006. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2008, APPROXIMATELY 24 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY AND PAIN. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THE PATIENT HAS A HIGH BMI WHICH INDICATES THAT THEY ARE OVERWEIGHT, THIS CAN INCREASE BIOMECHANICAL STRESSORS ON NATURAL AND ARTIFICIAL JOINTS. NO ADDITIONAL PATIENT MEDICAL HISTORY INFORMATION IS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 9703540 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2005. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2012, APPROXIMATELY 90 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: No Information

  MAUDE report 9703409 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, 155 CM, (B)(6) KG (BMI=(B)(6)), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE R KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK KNEE SYSTEM - CEMENTED CRUCIATE RETAINED (CR) FEMORAL COMPONENT - SIZE 2 (CATALOG 200-01-02, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/2T 2F/2T (CATALOG 200-04-22, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 2 - 11MM (CATALOG 200-22-11, SERIAL (B)(4)), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2014, APPROXIMATELY 62 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED.

  Patient problems: Bacterial Infection

  MAUDE report 9699582 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) YEARS OLD, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE RIGHT KNEE ON (B)(6) 2005. ON (B)(6) 2005, APPROXIMATELY 5 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. STERILE CERTIFICATION REVIEWED; DEVICES WERE STERILIZED AND RELEASED ACCORDING TO SPECIFICATIONS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Bacterial Infection

  MAUDE report 9695461 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-
• Z-0019-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200