Optetrak 208-23-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862054272), received between Nov 8, 2022 and Aug 28, 2024 — classified as 6 injuries.

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

• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA THIS PATIENT IS VERIFIED LEFT KNEE ON (B)(6) 2015 AT HOSPITAL FOR SPECIAL SURGERY. SHE HAD LEFT KNEE REVISION (B)(6) 2023 WITH DR (B)(6). IT WAS REPORTED THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, JOINT EFFUSION, AND COMPONENT LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20091116 ↗
• InjuryJul 18, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 104 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEARPAIN, STIFFNESS, SWELLING, DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19771345 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Synovitis

  MAUDE report 19341850 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2013, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 10 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE 15MM CC POLY WAS EXCHANGED FOR AN 18MM POLY. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS AVAILABLE AS IT IS AGAINST THE HOSPITAL POLICY. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18803747 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2007. SHE WAS IMPLANTED WITH AN OPTETRAK DEVICE. ON (B)(6) 2017, APPROXIMATELY 10 YEARS 2 MONTH POST INITIAL PROCEDURE, PLAINTIFF UNDERWENT LEFT TOTAL KNEE REVISION SURGERY DUE TO A ¿LEFT KNEE ASEPTIC LOOSENING.¿ UPON REMOVAL OF THE ORIGINAL TIBIAL INSERT, PLAINTIFF WAS IMPLANTED WITH A SECOND RECALLED OPTETRAK DEVICE IN HER LEFT KNEE. PLAINTIFF¿S REVISION SURGERY WAS DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE. FOLLOWING HER REVISION SURGERY, PLAINTIFF CONTINUED TO EXPERIENCE PAIN IN HER LEFT KNEE, AND PLAINTIFF WILL BE PROCEEDING WITH A RE-REVISION SURGERY TO REMOVE THE SECOND RECALLED OPTETRAK DEVICE IMPLANTED IN HER LEFT KNEE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16422298 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ELEVEN YEARS POST INITIAL LEFT SIDE TKA OF A 74 Y/O MALE PATIENT, THE SURGEON PERFORMED A WASH OUT OF THE INFECTED KNEE AND REPLACED THE POLY AS PART OF THE WASHOUT. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO DEVICE WAS DISPOSED BY THE HOSPITAL. NO ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15754719 ↗

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-