Optetrak 204-04-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862047649), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, IN OR AROUND (B)(6) 2012, REQUIRED A REVISION PROCEDURE AFTER IT WAS DISCOVERED THAT THE PLASTIC TIBIAL INSERT OF THE DEFECTIVE OPTETRAK TOTAL KNEE SYSTEM IMPLANT HAD FAILED, DURING WHICH THE PRIOR RIGHT KNEE PROSTHETIC DEVICE WAS REVISED AND THE PLASTIC TIBIAL INSERT WAS REPLACED WITH THE OPTETRAK TIBIAL INSERT (204-04-23) (HEREINAFTER REFERRED TO AS THE ¿2012 DEFECTIVE IMPLANT¿). ON OR AROUND, (B)(6) 2020 PLAINTIFF REQUIRED A SECOND REVISION PROCEDURE, APPROXIMATELY 7 YEARS 10 MONTHS POST PROCEDURE, DURING WHICH THE TOTAL KNEE PROSTHESIS WAS COMPLETELY REMOVED. PATHOLOGY TAKEN DURING THE (B)(6) 2020 SURGERY REVEALED THAT THE EXPLANTED TIBIAL COMPONENT (204-04-23) HAD FOCAL PITTING AND SCRATCHES WITH DELAMINATION PREDOMINANTLY ON THE MEDIAL COMPARTMENT. THE PATELLAR COMPONENT ALSO SHOWED WEAR DEFORMATION. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16491866 ↗

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-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-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-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.