Optetrak 208-25-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862054418), received between Feb 3, 2022 and Jan 2, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD BILATERAL TOTAL KNEE REPLACEMENTS (TKA) FOLLOWED BY THREE REVISIONS AND WAS SCHEDULED FOR A SECOND LEFT TKA REVISION. IT WAS INDICATED THAT THE REVISION WAS DUE TO RECALL OF DEVICE COMPONENTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. REFER TO THE FOLLOWING REPORT NUMBERS FOR PREVIOUS REVISIONS: 1038671-2022-01430 ¿ RIGHT KNEE REVISION 1 1038671-2022-01431 ¿ RIGHT KNEE REVISION 2 1038671-2022-01432 ¿ LEFT KNEE REVISION 1.

  Patient problems: Insufficient Information

  MAUDE report 21060056 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2005. APPROXIMATELY 16 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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: Bacterial Infection; Insufficient Information

  MAUDE report 16859538 ↗
• InjuryApr 13, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2012 AND WAS REVISED ON (B)(6) 2013. THE PATIENT PRESENTED WITH A PAINFUL CONSTRAINED RIGHT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE MARKED WEAR OF THE POLYETHYLENE ON X-RAY, BUT NOT GROSS EVIDENCE OF LOOSENING. HE HAD A LARGE EFFUSION AND POPLITEAL CYST THAT WAS PAINFUL. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT INCLUDING ACTIVITY MODIFICATION AND ANTI-INFLAMMATORY MEDICATIONS. THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION ON (B)(6) 2022. THERE WAS VERY EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE SEVERE WEAR OF THE LINER WITH DELAMINATION. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND THERE WAS A FRACTURE OF THE STEM AT THE FEMORAL COMPONENT JUNCTION. THE FEMORAL COMPONENT AND STEM WERE REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. ATTENTION WAS THEN TURNED TO THE TIBIA. THERE WAS SOME PERIPHERAL OSTEOLYSIS. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT THERE

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16740274 ↗
• InjuryApr 13, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  ADDITIONAL INFORMATION: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. REVISION SURGERY WAS APPROXIMATELY 4 MONTHS, 19 DAYS, POST INITIAL IMPLANT. 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; Discomfort; Emotional Changes; Failure of Implant; Implant Pain; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 16740217 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 16.02 YEARS POST RIGHT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO OSTEOLYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Osteolysis

  MAUDE report 13444999 ↗

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-