Optetrak 204-04-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862047700), received between Apr 30, 2025 and Jun 16, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND PAIN. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, SIGNIFICANT OSTEOLYSIS AROUND THE FEMORAL COMPONENT AND DAMAGE TO THE TIBIAL POLYETHYLENE AS A CONSEQUENCE OF CEMENT FRAGMENTATION. INTRAOPERATIVELY THE SURGEON OBSERVED THE TIBIAL INSERT WAS WELL FIXED BUT WAS ELECTED BY SURGEON TO REPLACE THE INSERT. IT WAS NOTED THERE WAS NO SIGNIFICANT OSTEOLYTIC CHANGES AFFECTING THE TIBIAL INSERT COMPONENT. THE SURGEON OBSERVED SYNOVITIS THROUGHOUT THE KNEE AND THE FEMORAL COMPONENT LOOSE WITH OSTEOLYTIC CYSTS IN THE FEMORAL CONDYLES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Discomfort; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 22211224 ↗
• InjuryApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY TEN YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT HAD A REVISION DUE TO A MASSIVE OSTEOLYSIS ISSUE DUE TO POLY WEAR. ALL IMPLANTS WERE REMOVED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint effusion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 21937201 ↗

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-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-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.