Optetrak 204-22-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862048257), received between Nov 21, 2019 and Aug 12, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A POLYETHYLENE WEAR. THERE WAS NO REPORTED SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Swelling/ Edema

  MAUDE report 19968829 ↗
• InjuryApr 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A FIRST REVISION LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED SECOND REVISION SURGICAL PROCEDURE ON (B)(6) 2017 APPROXIMATELY 3 MONTHS AFTER FIRST REVISION IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19095581 ↗
• InjuryApr 25, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT WAS REVISED ON (B)(6) 2017 WITH A NEW OPTETRAK TIBIAL INSERT, THEN APPROXIMATELY 4 YEARS, 7 MONTHS LATER (B)(6) 2022 WAS REVISED FOR A SECOND TIME TO A COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2022-POST OP DIAGNOSIS: PAINFUL TOTAL KNEE REPLACEMENT AND ASEPTIC LOOSENING LEFT KNEE. INDICATIONS: IN VIEW OF LOOSENING AROUND THE IMPLANT AND THE RECALL IMPLANT IT WAS ELECTED TO PROCEED WITH REVISION SURGERY. PROCEDURE: THE FEMORAL AND TIBIAL IMPLANTS WERE FREED FROM THE BONE USING OSTEOTOMES AND ¿GENTLE MALLETING¿. THE PATELLA COMPONENT WAS FOUND TO BE WELL-SEATED AND IN GOOD CONDITION AND WAS NOT REMOVED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT IN STABLE CONDITION. HOSPITAL CARE DAYS: ADMITTED (B)(6) 2022/DISCHARGED (B)(6) 2022. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Insufficient Information; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16806732 ↗
• InjuryOct 5, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT HAD A REVISION DUE TO POLY WEAR.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15546763 ↗
• InjuryNov 21, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A RIGHT KNEE WAS IMPLANTED IN 2014. A REVISION WAS SCHEDULED TO TAKE PLACE ON (B)(6) 2019. UPON OPENING THE KNEE, THE SURGEON NOTICED THAT THE POST OF THE INSERT WAS BROKEN OFF AND FREE FLOATING IN THE KNEE. UPON FURTHER EXPOSURE, HE RECOGNIZED THAT THE POLY WAS SEVERELY DELAMINATED ON THE LATERAL SIDE, ANTERIOR ASPECT, POST, AND PARTIALLY UNDERNEATH THE POLY. THE SURGEON THEN WASHED OUT THE PATIENT¿S KNEE, AND EXCHANGED THE POLY FOR AN SIZE 2, 22MM POLY, IN EXCHANGE FOR THE 15MM THAT WAS IN THERE PREVIOUSLY. THE SURGEON IS COMPLETING FURTHER OBSERVATION PRIOR TO SENDING DEVICE BACK. TO THIS MANUFACTURER. PATIENT IS (B)(6) AND ROUGHLY AROUND (B)(6). NO RELEVANT HISTORY IS KNOWN. INITIAL IMPLANT IN 2014.

  Patient problems: Failure of Implant

  MAUDE report 9353336 ↗

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-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-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-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.