Optetrak 208-25-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862054401), received between Jul 26, 2022 and Jan 28, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION. APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Osteolysis; Pain

  MAUDE report 21254187 ↗
• InjuryJul 11, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2010. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2011, APPROXIMATELY 1 YEAR 3 MONTHS AFTER THEIR PRIMARY PROCEDURE. THE PATIENT HAS REPORTED CONSTANT PAIN SINCE THE IMPLANTED DEVICE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 17301806 ↗
• InjuryJul 11, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2015. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 7 YEARS 2 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6) 2023 OP REPORT NOTES THAT THE PATIENT INDICATED FOR SURGERY DUE TO PROGRESSIVE PAIN AND SWELLING, AND THAT THE PATIENT HAD MODERATE EFFUSION WITHOUT ANY CLINICAL SIGNS OF INFECTION. THEY WERE ALSO NOTED TO HAVE HAD SIGNIFICANT INSTABILITY ESPECIALLY IN FLEXION WITH LATERAL LAXITY. INTRAOPERATIVE FINDINGS REVEALED ALL COMPONENTS TO BE WELL FIXED. THERE WAS A LARGE EFFUSION WITH NORMAL-APPEARING JOINT FLUID. THERE WERE NO SIGNS OF INFECTION. THERE WAS EXPECTED SYNOVIAL HYPERTROPHY CONSISTENT WITH POLYETHYLENE LINER WEAR. THE CONSTRAINED CONDYLAR POLYETHYLENE LINER HAD SEVERE MEDIAL SIDED WEAR WITH DELAMINATION, AND THERE WAS ALSO SEVERE WEAR INVOLVING THE INTERCONDYLAR SPINE. THE PATELLAR COMPONENT WAS ALSO SEVERELY WORN AND FELT TO BE APPROPRIATE FOR REVISION. THERE WAS CAVITARY OSTEOLYSIS PRIMARILY IN THE LATERAL FEMORAL CONDYLE. THERE WAS MINIMAL OR NO OSTEOLYSIS ON THE TIBIAL SIDE. THE TIBIA WAS REVISED DUE TO RELATIVE VALGUS POSITION THAT ADDED TO THE INSTABI

  Patient problems: Failure of Implant

  MAUDE report 17299689 ↗
• InjuryJun 7, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2007 AND THEN APPROXIMATELY 9 YEARS, 10 MONTHS LATER WAS REVISED ON (B)(6) 2017 FOR OSTEOLYSIS, BONE LOSS, SYNOVITIS COMPONENT LOOSENING, POLYWEAR AND DEBONDING, INSTABILITY, JOINT PAIN, STIFFNESS, AND SWELLING, FOREIGN BODY REACTION SYNOVITIS: INSUFFICIENT INFORMATION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Pain

  MAUDE report 17080412 ↗
• InjuryApr 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT ON (B)(6) 2008, A PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SURGERY WHERE HE WAS IMPLANTED WITH AN OPTETRAK CC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)); THEN ON (B)(6) 2017, APPROXIMATELY 9 YEARS AFTER IMPLANT, UNDERWENT A RIGHT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK CC POLYETHYLENE TIBIAL INSERT. DURING THIS REVISION PROCEDURE, THE PATIENT WAS IMPLANTED WITH A SECOND OPTETRAK LOGIC CC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)). IT IS STATED THAT THE PATIENT EXPERIENCES PAIN IN HIS RIGHT KNEE AND WILL LIKELY REQUIRE A RE-REVISION SURGERY OF THE RIGHT KNEE TO REMOVE THE POLYETHYLENE LINER. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16702480 ↗
• InjuryNov 9, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL BILATERAL TKA ON (B)(6) 1995. THE PATIENT HAD A PREVIOUS RIGHT KNEE REVISION ON (B)(6) 2010 DUE TO UNKNOWN REASONS. THE PATIENT'S RIGHT KNEE WAS REVISED AGAIN ON (B)(6) 2021 DUE TO UNKNOWN REASONS. NO FURTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 15759457 ↗
• InjuryJul 26, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED AN 86 YO MALE PATIENT UNDERWENT A REVISION ON THE LEFT SIDE KNEE DUE TO POLY WEAR AND PATELLA WEAR OF OPTETRAK CLASSIC CC KNEE DEVICES APPROXIMATELY 16 YEARS POST THE INITIAL IMPLANT DATE, AND WAS REVISED TO EXACTECH DEVICES. INITIAL IMPLANT YEAR IS 2006. NO DEVICES ARE AVAILABLE FOR RETURN AS THE FACILITY RETAINS THE DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 15106144 ↗

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-