Optetrak 204-25-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862048479), received between Aug 10, 2020 and Jun 25, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 76 Y/O MALE PATIENT'S KNEE WAS REVISED APPROXIMATELY 15 YEARS 4 MONTHS POST OP. PATIENT HAD POLY ISSUES WITH FLAKING AND DELAMINATION OF THE PATELLA ¿ THE THREE LUGS HAD SHEARED AWAY FROM THE PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: IT WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 19611439 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 144 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EXTENSIVE OSTEOLYSIS, BONE LOSS, EXTENSIVE SYNOVITIS, EXTENSIVE WEAR OF POLYETHYLENE LINER, MECHANICAL LOOSENING, EXTENSOR MECHANISM DISRUPTION, PAIN, SWELLING, AND JOINT STIFFNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19505178 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2020, APPROXIMATELY 4 YEARS, 5 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 19270840 ↗
• InjuryApr 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, 16 YEARS POSTOP THE INITIAL (B)(6) Y/O MALE PATIENT PRESENTED RECENTLY WITH A LEFT KNEE INFECTION. A I&D WAS PERFORMED WITH AN EXTENSIVE WASHOUT. THE JOINT WAS STABLE AFTER DEBRIDEMENT, SO THE SAME SIZE POLY WAS INSERTED. DUE TO THE SWELLING OF THE JOINT, MINIMAL INCISION, AND SUBLUXATION, IT WAS DIFFICULT TO INSERT THE FINAL IMPLANT. ONE POLY WAS WASTED DUE TO DEFORMITY WHILE IMPACTING. THERE WAS A 5-15 MINUTE DELAY WITH NO ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION REPLACING THE INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 11611933 ↗
• InjuryOct 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO RANGE OF MOTION/STIFFNESS. 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 10760104 ↗
• InjuryOct 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO INSTABILITY. 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 10702470 ↗
• InjuryOct 7, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2007, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT, OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10646603 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 37.7, UNDERWENT IMPLANTATION OF A INSERT TIB 5 11MM KNEE POST STAB OPTET. ON (B)(6) 2019, APPROXIMATELY 70 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 10389010 ↗

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-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-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-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.