Optetrak 204-01-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885862047571), received between Feb 11, 2020 and Oct 2, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K933494); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT A REVISION DUE TO RECALL/ADVISORY. NO OTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 20356278 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO PAIN. THE REASON FOR PAIN WAS NOT REPORTED. INITIAL SURGERY DATE WAS (B)(6) 2006. THE PATIENT HAD BILATERAL KNEE SURGERY; THE SIDE OF THE REVISION SURGERY WAS NOT REPORTED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 10946577 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO A BONE FRACTURE. INITIAL SURGERY DATE WAS (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10775724 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2005. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10760120 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2004. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10760051 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10661607 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2007, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2005. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10646599 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), 162 CM, (B)(6) (BMI=30), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK KNEE SYSTEM - CEMENTED POSTERIOR STABILISED (PS) FEMORAL COMPONENT - SIZE 2 (CATALOG 204-01-02, 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 - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 2 - 11MM (CATALOG 204-22-11, 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) 2015, APPROXIMATELY 49 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH ACS« SC FEMORAL COMPONENT CEMENTED SIZE 3 RIGHT, ACS« MB SC TIBIAL COMPONENT CEMENTED SIZE 3 AND ACS« MB SC PE- INSERT HYPERFLEX SIZE 3/10MM.

  Patient problems: Failure of Implant

  MAUDE report 9714820 ↗
• 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) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK KNEE SYSTEM - CEMENTED POSTERIOR STABILISED (PS) FEMORAL COMPONENT - SIZE 2 (CATALOG 204-01-02, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/3T 2F/3T (CATALOG 200-04-23, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 2 - 15MM (CATALOG 204-22-15, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 35MM (CATALOG 200-02-35, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2018, APPROXIMATELY 98 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA. THE EXACTECH FEMORAL COMPONENT REMOVED; TIBIAL COMPONENT REMOVED; TIBIAL LINER COMPONENT REMOVED AND REPLACED WITH PFC« SIGMA TC3 FEMORAL LEFT SIZE 2, MBT REVISION TIBIAL TRAY CEMENTED SIZE 2, TC3 RP TIBIAL INSERT SIZE 2 10MM.

  Patient problems: Failure of Implant

  MAUDE report 9713543 ↗
• InjuryFeb 14, 2020Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O (BMI=25), MALE 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 POSTERIOR STABILISED (PS) FEMORAL COMPONENT - SIZE 2 (CATALOG 204-01-02, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/3T 2F/3T (CATALOG 200-04-23, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 2 - 9MM (CATALOG 204-22-09, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2016, APPROXIMATELY 91 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA; WEAR OF POLYETHYLENE COMPONENT. THE EXACTECH WERE REMOVED AND REPLACED WITH NEXGEN ROTATING HINGE FEMORAL D LEFT, ROTATING HINGE KNEE PRECOAT TIBIAL PLATE SIZE 4 AND ARTICULAR SURFACE 17MM (FEM SIZE D).

  Patient problems: Failure of Implant

  MAUDE report 9711605 ↗
• InjuryFeb 14, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Adverse Event Without Identified Device or Use Problem; 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) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS RHEUMATOID ARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK KNEE SYSTEM - CEMENTED POSTERIOR STABILISED (PS) FEMORAL COMPONENT - SIZE 2 (CATALOG 204-01-02, 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 - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 2 - 11MM (CATALOG 204-22-11, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 29MM (CATALOG 200-02-29, SERIAL (B)(4), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2016, APPROXIMATELY 91 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY; WEAR OF POLYETHYLENE COMPONENT. THE EXACTECH WERE REMOVED AND REPLACED WITH OPTETRAK OFFSET TIBIAL TRAY 1F/1T AND 2F/1T BETA AND OPTETRAK KNEE SYSTEM - POSTERIOR STABILISED (PS) TIBIAL INSERT - SIZE 2 - 15MM.

  Patient problems: Failure of Implant

  MAUDE report 9711287 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), 165 CM, (B)(6) (BMI=30), 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) 2013, APPROXIMATELY 68 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIA, DISLOCATION/SUBLUXATION, INSTABILITY, AND PATIENT CONDITIONS (MALALIGNMENT). THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY (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. INSTABILITY IS A KNOWN RISK. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHE

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 9710045 ↗
• InjuryFeb 13, 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) 2007, APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE FEMUR AND 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 ADV

  Patient problems: Failure of Implant

  MAUDE report 9709978 ↗
• 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) 2007. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2010, APPROXIMATELY 45 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE 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. THIS PATIENT IS OVERWEIGHT, WHICH CAN CAUSE BIOMECHANICAL STRESSORS ON NATURAL JOINTS AND JOINT REPLACEMENTS. 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, BIOMECHANIC

  Patient problems: Failure of Implant

  MAUDE report 9709963 ↗
• InjuryFeb 13, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY ((B)(6)), THIS (B)(6) Y/O, (BMI=28), 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) 2017, APPROXIMATELY 108 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION; OTHER INDICATION FOR REVISION; WEAR OF POLYETHYLENE COMPONENT. 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.

  Patient problems: Bacterial Infection; Failure of Implant

  MAUDE report 9708055 ↗
• 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, 160 CM, (B)(6) KG (BMI=32), 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 15 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO COMPONENT DISSOCIATION, DISLOCATION AND SUBLUXATION (PARTIAL DISLOCATION). 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

  Patient problems: Joint Dislocation

  MAUDE report 9706832 ↗
• 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, 160 CM, (B)(6) KG (BMI=32), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2010, APPROXIMATELY 15 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO COMPONENT DISSOCIATION; DISLOCATION SUBLUXATION. 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. 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: Joint Dislocation

  MAUDE report 9703645 ↗
• InjuryFeb 11, 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, (BMI=44), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE RIGHT KNEE ON (B)(6) 2008. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) , APPROXIMATELY 17 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 (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. THERE HAS BEEN NO PATIENT MEDICAL HISTORY INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Bacterial Infection

  MAUDE report 9697189 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933494. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-0522-2007 · Dec 7, 2006 · Terminated
  Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13