Optetrak 208-23-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862054241), received between Oct 30, 2020 and May 16, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT A INITIAL TOTAL KNEE ARTHROPLASTY. FIVE YEARS LATER, SWELLING AND MILD POLYETHYLENE ASYMMETRY WERE OBSERVED ON RADIOGRAPHS. THREE YEARS AFTER THAT, TIBIAL OSTEOLYSIS WAS DETECTED AND REVISION SURGERY WAS PERFORMED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO RELEVANT MEDICAL HISTORY PROVIDED.

  Patient problems: Osteolysis; Swelling/ Edema

  MAUDE report 22035865 ↗
• InjuryMar 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 11 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Joint effusion; Metal Related Pathology; Synovitis

  MAUDE report 18956971 ↗
• InjurySep 12, 2023Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 162 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, JOINT LAXITY, LOSS OF RANGE OF MOTION, OSTEOLYSIS, AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Synovitis

  MAUDE report 17728297 ↗
• InjuryJun 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DEPARTMENT A FEMALE PATIENT HAD A BILATERAL KNEES ON (B)(6) 2007. APPROXIMATELY 15 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD BILATERAL KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022: POSTOP DIAGNOSIS: POLYETHYLENE PARTICULATE DEBRIS-INDUCED SYNOVITIS BILATERAL KNEES STATUS POST BILATERAL TOTAL KNEE REPLACEMENT IN 2007. FINDINGS: ON THE RIGHT KNEE THERE WAS A MODERATE DEGREE OF SYNOVITIS. FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE PATELLAR COMPONENT WAS NOT LOOSE BUT THERE WAS WEAR OF THE POLYETHYLENE. THERE WAS WEAR ON THE ANTERIOR ASPECT OF THE POST FOR THE CPK LINER. A COMPRESSIVE STERILE DRESSING WAS THEN APPLIED TO THE KNEE AND THE PATIENT BROUGHT TO RECOVERY IN STABLE CONDITION.

  Patient problems: Synovitis

  MAUDE report 17198772 ↗
• InjuryNov 2, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A 71 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2009 WITH POLYETHYLENE TIBIAL LINING MANUFACTURED BY EXACTECH, INC, SUFFERED PERSONAL INJURIES FROM THAT SURGERY, INCLUDING BUT NOT LIMITED TO BONE LOSS AND THE NEED FOR FURTHER SURGERY. NO ADDITIONAL INFORMATION.

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

  MAUDE report 15718528 ↗
• InjurySep 1, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL, THAT A PATIENT HAD A RIGHT KNEE OPTETRAK IMPLANT DATE: (B)(6) 2017 WITH REVISION DATE: (B)(6) 2022. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 15334499 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT RETURNED TO HSS 20 YEARS AFTER A TOTAL KNEE REPLACEMENT COMPLAINING OF PAIN AND INSTABILITY. THE FEMUR AND TIBIA SEEMED TO BE WELL FIXED SO THE INSERT WAS REMOVED AND A 15MM CCK INSERT WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL RETAINS ALL RETRIEVALS.

  Patient problems: Failure of Implant

  MAUDE report 11783804 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10760150 ↗

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-