Optetrak 204-04-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862047717), received between Oct 14, 2020 and Feb 13, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 63 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, JOINT LAXITY, METAL RELATED PATHOLOGY, OSTEOLYSIS, PAIN, SCAR TISSUE, SYNOVITIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21374730 ↗
• InjuryFeb 5, 2025Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY 84 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND SCAR TISSUE. 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: Osteolysis; Scar Tissue

  MAUDE report 21315351 ↗
• InjuryJul 15, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 14.5 YEARS AFTER INITIAL TOTAL KNEE REPLACEMENT, THE PATIENT EXPERIENCED INSTABILITY. DURING REVISION, THE IMPLANTS WERE FOUND TO BE LOOSE. THIS EVENT IS NOT RELATED TO A BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: HOSPITAL POLICY.

  Patient problems: Joint Laxity

  MAUDE report 19740055 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) OF 2009, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 15 YEARS POST THE INITIAL PROCEDURE. REVISION DATE UNKNOWN. THE SURGEON REMOVED THE OPTETRAK PS KNEE DUE TO POLY WEAR. THERE WERE SIGNS OF WEAR ON THE PATELLA AND LINER. THERE WERE ALSO SIGNS OF METALLOSIS. THERE WAS AN ABSENCE OF CEMENT ON A SIGNIFICANT PORTION OF THE BACKSIDE SURFACE OF THE FEMORAL COMPONENT. THE SURGEON REPLACED ALL COMPONENTS WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. LEGAL INDICATED FOR THE REASON. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 19620810 ↗
• InjuryApr 15, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THIRTEEN YEARS POST INITIAL LEFT TKA, THIS (B)(6) PATIENT WAS HAVING PAINFUL KNEE AND CAME TO SURGEON WITH DISCOMFORT AND SWELLING. UPON EVALUATION SURGEON FELT A LINER EXCHANGE WOULD HELP. INTRA OPERATIVELY SURGEON FOUND METALLOSIS AND A MAN HOLE COVER THAT CAME DISCONNECTED FROM THE TIBIA. IT WAS STUCK BETWEEN THE LINER AND PROXIMAL TIBIA TRAY. ALSO THE PATELLA HAD SOME WEAR TO IT. THERE WAS NO OSTEOLYSIS. SO SURGEON REPLACED IT. SURGEON PLACED A 5/11MM PS AND REVISED THE PATELLA TO A 38MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14118194 ↗
• InjuryMar 29, 2022Crack; Crack

  AS REPORTED, APPROXIMATELY ELEVEN YEARS POST INITIAL TKA, THIS (B)(6) MALE PATIENT HAD A REVISION SURGERY DUE TO THE TIBIAL TRAY WAS CRACKED DUE TO ASYMMETRIC LOADING. THERE WAS EVIDENCE OF POLY WEAR, PITTING AND OXIDATION AND GROSS WEAR THROUGH POLY INTRAOP. PREOP, PATIENT HAD A BROKEN TIBIAL TRAY WITH FAILURE OF TIBIA TRAY IN VARUS AND LARGE MEDIAL TIBIAL OSSEOLYRIC DEFECT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS HE REQUESTED IT AND HAS IN HIS POSSESSION.

  Patient problems: Failure of Implant

  MAUDE report 13938518 ↗
• InjuryApr 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) MALE PATIENT RETURNED TO HSS EXPERIENCING RIGHT KNEE PAIN 10 YEARS AFTER RECEIVING A REVISION KNEE REPLACEMENT. THE TIBIA WAS THE ISSUE AND THE SURGEON DECIDED TO REVISE ONLY THE TIBIAL COMPONENT IF THE FEMUR WAS WELL FIXED. UPON EXPOSURE IT WAS DETERMINED THAT THE FEMORAL COMPONENT WAS WELL FIXED, AND THE SURGEON DECIDED TO PERFORM A TIBIAL REVISION. THE PATIENT HAD A SIZE 5 FEMUR AND TIBIAL COMPONENTS BOTH AUGMENTED. DUE TO MINOR BONE LOSS UPON FURTHER RESECTION, HE DECIDED TO GO DOWN ON THE TIBIA TO A SIZE 4 TRAY. THE TIBIAL AUGMENT WENT DOWN FROM AN 11MM TO AN 8MM STAYING WITH A 1/3 COVERAGE. THE KNEE WAS DEEMED STABLE USING AN 18MM CCK INSERT. HAVING USED A 120MM STEM ON THE PREVIOUS REVISION THE SURGEON DECIDED TO GO WITH A 160MM STEM FOR THIS REVISION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL RETAINS ALL RETRIEVALS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 11611936 ↗
• 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 RIGHT 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 10946482 ↗
• 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) 2004. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10702476 ↗
• 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 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 10681635 ↗

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-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-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-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.