Optetrak 204-25-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862048486), received between Dec 15, 2020 and Nov 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryNov 12, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2009. HE HAD LEFT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 13 YEARS 5 MONTHS AFTER THEIR INITIAL IMPLANTATION. HE HAS DEVELOPED PROGRESSIVE PAIN AND DEBILITATION RELATED TO HIS LEFT KNEE. HIS X-RAYS SHOWED WHAT APPEARED TO BE LOOSENING OF THE FEMORAL COMPONENT WITH DEBONDING OF THE ANTERIOR FLANGE WITH THE CEMENT MANTLE. THE PATELLAR COMPONENT WAS WELL FIXED HOWEVER WAS SEVERELY WORN AND THEREFORE, REPLACED. THE FEMORAL COMPONENT HAD SIGNIFICANT DEBONDING OF THE CEMENT PROSTHETIC INTERFACE UNDER THE ANTERIOR FLANGE AND WAS EASILY REMOVED. THERE ALSO APPEARED TO BE LOOSENING OF THE TIBIAL COMPONENT AS IT WAS REMOVED FROM ITS CEMENT MANTLE RELATIVELY EASILY. THE POLYETHYLENE LINER HAD MINIMAL WEAR EXCEPT FOR ON THE ANTERIOR PORTION OF THE TIBIAL SPINE. THERE WAS SYNOVIAL HYPERTROPHY CONSISTENT WITH COMPONENT LOOSENING. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, DISCOMFORT, PAIN, SYNOVITIS, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 20663156 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2016. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11009305 ↗

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-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.