Optetrak 208-23-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862054265), received between Mar 12, 2021 and Nov 12, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 56 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20665679 ↗
• InjuryNov 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 187 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20615014 ↗
• InjurySep 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 133 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS & OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Synovitis

  MAUDE report 20171802 ↗
• InjurySep 5, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - USA. PATIENT ID: (B)(6). SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. IT WAS REPORTED THAT APPROXIMATELY 50 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. UDI: (B)(4). 510K: K954208.

  Patient problems: Cyst(s); Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 20144941 ↗
• InjuryJun 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 156 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT. PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, PAIN, DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING; COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS AND OTHER INJURIES PRESENTLY UNDIAGNOSED WHICH WILL ALL REQUIRE ONGOING MEDICAL CARE. . POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE."

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

  MAUDE report 19615572 ↗
• InjuryJun 26, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ELEVEN YEARS POST INITIAL TKA, PATIENT WAS REVISED DUE TO PAIN AND BAD OSTEOLYSIS. THERE WAS NO ISSUES REMOVING COMPONENTS. COMPETITOR'S REVISION KNEE WAS IMPLANTED. THE EXPLANTS ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION.

  Patient problems: Osteolysis; Pain

  MAUDE report 17201743 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 208-23-13-INSERTO TIBIAL CC 3,13MM, SERIAL NUMBER: (B)(6) ON (B)(6) 2019. THE INSERT WAS MANUFACTURED ON 5-JUL-2016 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 5-JUL-2016 AND WAS 3 YEARS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY FOUR YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 16971078 ↗
• InjuryMay 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A FEMALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 11 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION DUE TO PROSTHESIS WEAR. 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. OP REPORT (B)(6) 2023/ K MCGUINNESS RECEIVED VIA LEGAL (B)(6) 2023. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT KNEE DUE TO POLYETHYLENE WEAR. FINDINGS: PARTIAL LOOSE FEMORAL AND TIBIAL COMPONENTS WITH MILD TO MODERATE AMOUNT OF OSTEOLYSIS BEHIND THE FEMORAL COMPONENT AND AROUND THE TIBIAL COMPONENT. THE PATELLAR COMPONENT WAS WELL FIXED BUT ALSO HAD A MODERATE AMOUNT OF POLYETHYLENE WEAR. AN ACE WRAP FROM TOE TO THIGH WAS APPLIED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITIONS WITH NO COMPLICATIONS.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 16876222 ↗
• InjuryMar 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT 58 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 2 YEARS 1 MONTH POST THE INITIAL PROCEDURE DUE TO POLY WEAR. THE INSERT WAS REPLACED. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 16591531 ↗
• InjuryMar 12, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED, APPROXIMATELY 8 YRS POSTOP THE INITIAL IMPLANT, THE RIGHT CCK LINER WAS REPLACED BY A NEW CCK IMPLANT IN THIS THIS MALE PATIENT. SURGEON SUSPECTED THAT IT IS THE BACKING OF THE STUFFING SCREW CAUSED THE COMPONENTS TO SEPARATE DURING RANGE OF MOTION AND RESULT IN INSTABILITY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING FOR EVALUATION DUE TO HOSPITAL DISPOSED THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 11474822 ↗

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-