Optetrak 204-04-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862047625), received between Oct 14, 2020 and Feb 6, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 115 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, JOINT LAXITY, SYNOVITIS, OSTEOLYSIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 21327529 ↗
• InjuryDec 5, 2024Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 143 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF POLYETHYLENE LINER, OSTEOLYSIS, ASEPTIC LOOSENING. REVISION OPERATIVE REPORT WAS PROVIDED, AND FINDINGS CONCLUDE THAT PATIENT WAS NEGATIVE FOR INFECTION. POLYETHYLENE LINER WAS WORN AND SEPARATED FROM THE TIBIAL PLATE PLACE AND EVIDENCE OF METAL-ON-METAL ARTICULATION AFTER THE POLYETHYLENE FAILURE, AS WELL AS ASEPTIC LOOSENING AND OSTEOLYSIS OF THE FEMORAL AND TIBIAL COMPONENTS. THERE WAS A CENTRAL AREA OF BONE LOSS IN THE TIBIA AND A FAIRLY LARGE MEDIAL FEMORAL CONDYLE BONE LOSS AS WELL AS CENTRAL BONE LOSS IN THE FEMUR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 20854140 ↗
• InjuryNov 21, 2024Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 135 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR POLYETHYLENE WEAR, OSTEOLYSIS, ASEPTIC LOOSENING. OPERATIVE REPORT NOTES THE KNEE APPEARED TO BE LIGAMENTOUS GROSSLY LOOSE AS WELL AS FAIRLY SIGNIFICANT POLYETHYLENE LINER WEAR THAT I SUSPECTED HAD ALREADY WORN COMPLETELY THROUGH. IT WAS OBVIOUSLY NOTABLE INITIALLY UPON ENTERING THE JOINT THAT SHE HAD SEVERE BLACKENED SYNOVITIS DUE TO THE METAL-ON-METAL ARTICULATION AND COMPLETE POLYETHYLENE FAILURE AND CATASTROPHIC DISLODGEMENT. THERE WAS NOTABLE BONE LOSS BOTH ON THE MEDIAL AND LATERAL FEMORAL CONDYLE THAT SEEMED TO BE UNCONTAINED. THE TIBIAL HAD A CENTRAL DEFECT AS WELL AS AN UNCONTAINED DEFECT ON THE LATERAL CONDYLE. THE PATELLA APPEARED TO BE GROSSLY INTACT WITH GOOD TRACKING AND WAS RETAINED. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO APPARENT COMPLICATIONS AND NO DEVIATIONS IN SURGICAL PLAN. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 20751444 ↗
• InjuryNov 14, 2024Mechanical Problem; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF LEFT KNEE TOTAL KNEE ARTHROPLASTY PROSTHESIS WITH LOOSE COMPONENTS; CORTICAL FRACTURE OF LEFT FEMUR; SEVERE OSTEOLYSIS, LOSS OF RANGE OF MOTION; CHRONIC PAIN; INJURIES TO TISSUE AND CONE OF THE LEFT KNEE; SUBCHONDRAL CYST; JOINT EFFUSION; METALLOSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Bone Fracture(s); Cyst(s); Failure of Implant; Implant Pain; Joint effusion; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 20689328 ↗
• 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) 2017, DUE TO 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 10946566 ↗
• 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 10808442 ↗
• 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) 2005. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681642 ↗

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-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-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-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.