Optetrak 204-04-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10885862047656), received between Oct 29, 2019 and Jun 30, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (28 reports).

7 other recalls cover devices cleared under the same FDA submission (K933610); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #3 OF 3 FOR THIS EVENT. IT WAS REPORTED VIA LEGAL DOCUMENTATION A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR LATER, THE PATIENT UNDERWENT A REVISION OF THE TIBIAL INSERT AND FEMORAL COMPONENTS. NO MEDICAL OR CLINICAL INFORMATION WAS PROVIDED. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT CONTINUES TO EXPERIENCE DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND INCLUDING BUT NOT LIMITED TO GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 25670543 ↗
• InjuryMay 11, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 2 IT WAS REPORTED A PATIENT UNDERWENT A TOTAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THIRTEEN (13) YEARS LATER, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AND TIBIAL POLYETHYLENE WEAR/DELAMINATION. IMAGES AND RADIOGRAPHS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25143349 ↗
• InjuryFeb 4, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL NOTIFICATION THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIX (6) YEARS LATER, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE TO ADDRESS OSTEOLYSIS, ASEPTIC LOOSENING OF THE TIBIAL COMPONENTS AND DEVELOPMENT OF COMPLEX REGIONAL PAIN SYNDROME SECONDARY TO POLYETHYLENE WEAR. ADDITIONALLY, IT WAS NOTED THAT DESPITE UNDERGOING REVISION SURGERY THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT THE PATIENT'S ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS THE PATIENT'S QUALITY OF LIFE. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Metal Related Pathology; Osteolysis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24262352 ↗
• InjuryAug 15, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY DUE TO OSTEOARTHRITIS. THEY UNDERWENT RIGHT KNEE REVISION SURGERY APPROXIMATELY 8 YEARS 8 MONTHS POST PRIMARY PROCEDURE. OPERATIVE REPORT OPERATIVE FINDINGS: GROSS PURULENCE AND INFECTION, LOOSE FEMORAL COMPONENT, LOOSE TIBIAL COMPONENT, WELL-FIXED PATELLAR COMPONENT, ADEQUATE SOFT TISSUE COVERAGE, AORI CLASS FEMUR 2B, AORI CLASS TIBIA 2B. POSTOPERATIVE DIAGNOSIS: PYOGNEIC ARTHRITIS OF RIGHT KNEE JOINT, DUE TO UNSPECIFIED ORGANISM. THE SURGEON NOTED ABUNDANT PURULENCE. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND COMPLETELY DEBONDED FROM THE BONE, WHERE ABUNDANT PURULENCE WAS NOTED IN THE FEMUR AROUND THE IMPLANT, WHICH WAS REMOVED. THE POLYETHYLENE WAS REMOVED AND THE TIBIAL COMPONENT WAS ALSO NOTED TO BE LOOSE WITH SEVERE BONE LOSS AND PURULENCE IN THE BONE. THE PATELLAR BONE HAD OSTEOLYSIS AS WELL OVER THE LATERAL FACET. SHE TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Swelling/ Edema; Unspecified Infection

  MAUDE report 22816073 ↗
• InjuryMay 20, 2025Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  IT IS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT UNDERWENT REVISION PROCEDURE TO ADDRESS DEVELOPING INCREASING MECHANICAL SYMPTOMS. SPECIFICS AS REPORTED: FAILED LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING AND POLYETHYLENE LINER WEAR. STANDARD ANTERIOR APPROACH TO THE KNEE USING OLD INCISION. POLYETHYLENE LINER WAS LOOSE, AND IT CAME OUT WITHOUT EFFORT. POLYETHYLENE WAS COMPLETELY WORN THROUGH THE POSTERIOR LATERAL ASPECT. THERE WERE MULTIPLE PIECES OF PLASTIC THAT WERE PULLED OUT AS WELL, THESE WERE SMALL IN NATURE AND THE LARGEST ONE MEASURED PROBABLY 6-7 MM. FEMUR CAME OUT BY PULLING IT AFTER HITTING IT ONLY 2 OR 3 TIMES. 100% OF THE CEMENT REMAINED ON THE END OF THE BONE. TIBIA HAD GOOD INGROWTH BUT AGAIN WAS SLIGHTLY EASY TO REMOVE.

  Patient problems: Pain; Scar Tissue; Synovitis

  MAUDE report 22054996 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Synovitis

  MAUDE report 21546540 ↗
• InjuryFeb 5, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, METAL RELATED PATHOLOGY, DISCOMFORT, PAIN, OSTEOLYSIS, SCAR TISSUE AND SYNOVITIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21316093 ↗
• InjuryJan 6, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  ON (B)(6) 2008, PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN EXACTECH KNEE SYSTEM. AT THE TIME OF THE IMPLANT, THE EXACTECH KNEE SYSTEM IMPLANTED INTO PATIENT WAS IN SUBSTANTIALLY THE SAME CONDITION AS WHEN IT LEFT DEFENDANTS' CONTROL. IN THE ENSUING TIME, PATIENT BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH THE DEFECTS OF THE EXACTECH KNEE SYSTEM AS ALLEGED IN THIS COMPLAINT, INCLUDING PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, PATIENT UNDERWENT A REVISION OF THE LEFT TOTAL KNEE ON (B)(6) 2020. PATIENT EXPERIENCES, PAIN, LACK OF MOBILITY, AND ENDURING LIMITATIONS ON ACTIVITIES OF DAILY LIVING, QUALITY OF LIFE AND ABILITY TO PERFORM WORK FUNCTIONS. MECHANICAL LOOSENING OF INTERNAL LEFT KNEE PROSTHETIC JOINT; WORSENING INSTABILITY. CLEAR SYNOVIAL FLUID SENT FOR ASPIRATE. FEMORAL COMPONENT WAS REMOVED WITHOUT ANY BONE LOSS. UTILIZED A RONGEUR TO PULL THE TIBIAL DIRECTLY OUT. IT WAS IN CONSIDERABLE VARUS SUBSIDENCE MEDIALLY. SIGNIFICANT METAPHYSEAL BONE OSTEOLYSIS IN TIBIAL COMPONENT. REVISION LEFT TKA. PATIENT WAS AWAKE, ALERT, AND ORIENTED IN STABLE CONDITION WHEN TRANSFERRED FROM PACU TO FLOOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 21082508 ↗
• InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF LEFT TOTAL KNEE REPLACEMENT SECONDARY TO POLYETHYLENE LINER RESULTING IN BONE LOSS AND A LOOSE TIBIAL COMPONENT AS WELL LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. A WEAR AND BREAKING OF THE POLYETHYLENE LINER, OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 20663094 ↗
• InjuryAug 13, 2024Unstable; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, GROOVING AND DELAMINATION OF THE PATELLA RESULTING IN A GROSSLY LOOSE TIBIAL COMPONENT AS WELL AS LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Joint Laxity; Synovitis

  MAUDE report 19974181 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BONE LOSS, LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity

  MAUDE report 19523973 ↗
• InjuryDec 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2010. THE PATIENT PRESENTED ON (B)(6) 2018 WITH INCREASING PAIN. PATIENT SAW ORTHO ON (B)(6) 2018 COMPLAINING OF 2 YEARS OF INCREASING PAIN TO RIGHT (OPERATIVE) KNEE. X-RAY SHOWS QUESTION TIBIAL LOOSENING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME IS RESOLVED ON (B)(6) 2019 WITH X-RAY FOLLOW UP IN 4 MONTHS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18280274 ↗
• InjuryDec 22, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS POSTOP THIS (B)(6) MALE PATIENT¿S RIGHT KNEE, THE PATIENT WAS REVISED DUE TO THE TIBIAL COMPONENT LOOSENED AND THE PATIENT HAD PAIN IN KNEE. THE TIBIAL COMPONENT WAS REVISED. UTILIZED STEMMED TIBIAL COMPONENT. FEMUR AND PATELLAR COMPONENTS WERE NOT REVISED. DEVICES NOT RETURNING, DISCARDED AT TIME OF SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. CONCOMITANT DEVICE: SIZE 3, 11MM INSERT OPTETRAK INSERT (CN: 204-23-11, SN: (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 11060035 ↗
• InjuryDec 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2005. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946545 ↗
• InjuryDec 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946527 ↗
• InjuryNov 9, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10808440 ↗
• InjuryNov 9, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10808437 ↗
• InjuryNov 9, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10808436 ↗
• InjuryOct 30, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760047 ↗
• InjuryOct 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2004. THE PATIENT HAD BILATERAL KNEE ARTHROPLASTY, THE SIDE OF REVISION SURGERY IS NOT REPORTED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10702469 ↗
• InjuryOct 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10702468 ↗
• InjuryOct 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2004. THE PATIENT HAD A BILATERAL KNEE ARTHROPLASTY, THE SIDE OF THE REVISION SURGERY WAS NOT REPORTED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10702465 ↗
• InjuryOct 15, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10687545 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2009, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681631 ↗
• InjuryOct 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2005. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10661611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.