Optetrak 208-22-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862054210), received between Nov 22, 2021 and Sep 20, 2024 — classified as 3 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.

1 other recall cover devices cleared under the same FDA submission (K954208); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). CASE-(B)(4) RK REV 1 IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 73 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20271864 ↗
• InjuryDec 21, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2014. THIS DEVICE HAS NOT BEEN EXPLANTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO.(B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18373355 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A POLY SWAP WAS SCHEDULED FOR (B)(6) 2021. ALL NEEDED MATERIALS (IMPLANTS AND INSTRUMENTS) WERE PREPARED THE DAY BEFORE. THE IMPLANT RECORD WAS OBTAINED. THE SURGEON WAS TOLD HIS ONLY OPTIONS WERE REPLACING THE 22MM INSERT THAT WAS IN THERE OR INCREASING TO A 26MM OR 30MM. EARLY IN THE DAY ON THE DATE OF SURGERY WE (REP AND SURGEON'S STAFF) LOOKED AT THE PICS OF THE CASE AND INFORMED THE SURGEONS OF OUR CONCERNS. THE FEMUR NEEDED TO BE REVISED AND DUE TO THE SIZES OF EXISTING IMPLANTS OUR SYSTEMS PARAMETERS MAY NO COVER THE GAP AND A TOTAL FEMUR MAY BE NEEDED. THE SURGEON CANCELED THE PROCEDURE ON THE LEFT KNEE AND PROCEEDED TO SCOPE THE RIGHT KNEE. PATIENT WAS SCHEDULED FOR A POLY SWAP. THAT WAS DEEMED INADEQUATE IN A GROUP DISCUSSION. THE PROCEDURE WAS CANCELED AND REFERRED TO A REVISION SPECIALIST. PATIENT CONTINUED ON WITH SCOPE OF RIGHT KNEE BUT LEFT KNEE REVISION WAS CANCELLED AND REFERRED TO ANOTHER HSS SURGEON. THE WERE NO DEVICES REMOVED TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED INDICATES THAT LEFT KNEE REVISION WAS SCHEDULED DUE TO MASSIVE INSTABILITY AND PAIN.

  Patient problems: Failure of Implant

  MAUDE report 12856389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• 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-