Optetrak Logic 02-012-47-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862174352), received between Dec 7, 2021 and Jul 1, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0583-2024 · Root cause: Packaging change control · FDA record ↗

2. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Naturally Worn

  IT WAS REPORTED THAT A LEFT TKA, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THEY NEEDED TO BE REVISED DUE TO THE WRONG PACKED LINERS. MASSIVE WEAR REPORTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE REPORT INDICATED NO X-RAYS WERE NEEDED; THEREFORE NONE ARE AVAILABLE. THE EXPLANT IS AVAILABLE FOR RETURN. IMAGES OF THE IMPLANT WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 25682661 ↗
• InjuryAug 12, 2024Naturally Worn; Naturally Worn

  AS REPORTED, 6 YEARS AND 2 MONTHS POST THE INITIAL BILATERAL TKA, A BONE SCAN SHOWED LOW LEVEL HEAT ON BOTH KNEES. THE SURGEON REMOVED THE POLY TIBIAL INSERTS AND LEFT SIDE PATELLA, WHICH ALL SHOWED EVIDENCE OF WEAR AND MILD OSTEOLYSIS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 19964638 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 34 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, STIFFNESS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain

  MAUDE report 19335078 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A FUTURE REVISION PROCEDURE DUE TO POLYETHYLENE WEAR. THE PATIENT HAS EXPERIENCED PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 19309026 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED.THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19085806 ↗
• InjurySep 27, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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) 2023: DIAGNOSIS: FAILED RIGHT PATELLA IMPLANT AND POLYETHYLENE INSERT POLYETHYLENE INSERT WAS REMOVED WHICH SHOWED EXCESSIVE WEAR. THE PATELLA EVERTED, SHOWED EXTENSIVE WEAR. THE PATIENT WAS BROUGHT TO RECOVERY ROOM IN STABLE CONDITION.

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

  MAUDE report 17823824 ↗
• InjuryMar 1, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL, OVER A PERIOD OF TIME, THE PATIENT'S RIGHT KNEE BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH EXCESSIVE WEAR OF THE EXACTECH KNEE DEVICES, INCLUDING BUT NOT LIMITED TO PAIN AND LACK OF MOBILITY. AS A DIRECT AND PROXIMATE RESULT OF THE FAILURE OF THE EXACTECH DEVICES, PATIENT HAS BEEN REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE EXACTECH DEVICES, AND NOW HAS COMPONENTS WITH DECREASED LONGEVITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Failure of Implant; Pain

  MAUDE report 16463668 ↗
• InjuryMar 1, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL, OVER A PERIOD OF TIME, THE PATIENT'S RIGHT LEFT BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH EXCESSIVE WEAR OF THE EXACTECH KNEE DEVICES, INCLUDING BUT NOT LIMITED TO PAIN AND LACK OF MOBILITY. AS A DIRECT AND PROXIMATE RESULT OF THE FAILURE OF THE EXACTECH DEVICES, PATIENT HAS BEEN REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE EXACTECH DEVICES, AND NOW HAS COMPONENTS WITH DECREASED LONGEVITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 16463149 ↗
• InjuryDec 7, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YRS POSTOP THE INITIAL RIGHT TKA, THE POLY SHOWED SIGNIFICANT POLY WEAR AND THE (B)(6) MALE PATIENT WAS REVISED THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 12956464 ↗