Optetrak 204-26-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862048554), received between Dec 7, 2020 and Mar 5, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 13 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. PER POSTOPERATIVE DIAGNOSIS STATED IN OP REPORT: FAILED RIGHT KNEE (ADVANCED WEAR OF POLYETHYLENE LINER WITH SEVERE SOFT TISSUE REACTION. REVISED TO COMPETITOR'S DEVICES (FEMORAL, TIBIAL, AND PATELLA COMPONENTS). NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18835393 ↗
• InjuryFeb 14, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2014 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 5 YEARS 5 MONTHS POST INITIAL PROCEDURE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN HIS LEFT KNEE WHICH LIMITS HIS DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16372929 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 11.43 YEARS POST TKA, THIS PATIENT UNDERWENT A REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13442552 ↗
• InjuryDec 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO PROSTHESIS FRACTURE. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10959475 ↗

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.