Optetrak 204-04-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862047687), received between Dec 4, 2020 and Dec 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE IMPLANT FAILED CLINICALLY, RESULTING IN MAJOR BONE OSTEOLYSIS AND NECESSITATING REVISION SURGERY. EVERYTHING WAS FINE UNTIL ABOUT 1.5 YEARS AGO WHEN PAIN, EFFUSION AND DECREASED MOBILITY BEGAN. X-RAY SHOWING OSTEOLYSIS OF THE POSTERIOR CONDYLES; COMPARING THIS X-RAY WITH THE ONE FROM 2019, DEGENERATION IS EVIDENT. RADIOLUCENT LINES ARE SEEN SURROUNDING BOTH COMPONENTS, WHICH SHOULD BE EVALUATED CLINICALLY (POSSIBLE LOOSENING?). BONE BIOPSIES AND MICROBIOLOGICAL AND HISTOLOGICAL STUDIES RULE OUT INFECTION. INFECTIOUS COMPLICATION; FALL; PRESSURE ULCER; SURGICAL WOUND INFLAMMATION; REINTERVENTION. REMOVAL OF PTJ DTA WITH FINDINGS OF EXTENSIVE SYNOVITIS AND MASSIVE TIBIAL AND FEMORAL OSTEOLYSIS AND REVISION ARTHROPLASTY WITH CEMENTED TIBIA AND FEMORAL SLEEVE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. THE PATIENT SUFFERED PERMANENT DISABILITY AS AS DIRECT RESULT OF THIS EVENT.

  Patient problems: Fall; Loss of Range of Motion; Radiolucent Lines; Skin Inflammation/ Irritation; Synovitis

  MAUDE report 23827593 ↗
• InjuryJan 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 122 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ADVANCED METALLOSIS AND OSTEOLYSIS OF THE FEMUR AND TIBIA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Metal Related Pathology; Osteolysis

  MAUDE report 21091778 ↗
• 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 ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2009. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946452 ↗

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-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-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-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.