Optetrak Logic 02-012-44-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862173591), received between May 3, 2023 and Aug 15, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 reports).

1 FDA recall record name this device's identifier, 1 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. 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-0021-2022 · 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.

• InjuryAug 15, 2024Unstable; Naturally Worn; Lack of Effect; Unstable; Naturally Worn; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19996086 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 90 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 19984974 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 110 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS COMPONENT LOOSENING. THE PATIENT WAS PRESENTED WITH SIGNIFICANT PERIPROSTHETIC OSTEOLYSIS AND ASEPTIC LOOSENING OF THEIR RIGHT TOTAL KNEE ARTHROPLASTY WITH ASSOCIATED PAIN REFRACTORY TO COMPREHENSIVE NONOPERATIVE MANAGEMENT IN THE SETTING OF A RECALLED EXACTECH TOTAL KNEE DEVICE. DURING THE PROCEDURE THERE WAS NOTED SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION CONSISTENT WITH POLYETHYLENE WEAR AND COMPONENT LOOSENING. THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND WAS EASILY EXPLANTED WITH GENTLE DISIMPACTION USING A ROUND IMPACTOR. THERE WAS COMPLETE DE-BONDING OF THE COMPONENT WITH NO EVIDENCE OF AN IMPLANT-CEMENT INTERFACE. UPON REMOVAL OF THE CEMENT THERE WAS A LARGE CONTAINED CAVITARY OSTEOLYTIC DEFECTS INVOLVING THE LATERAL AND MEDIAL FEMORAL CONDYLES. THE PATELLAR BUTTON WAS INSPECTED AND DETERMINED TO BE LOOSE. THE TIBIAL COMPONENT REMAINED WELL-FIXED. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WE

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

  MAUDE report 19481589 ↗
• InjuryMay 16, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT AND LOOSE FEMORAL AND TIBIAL COMPONENTS. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 19331054 ↗
• InjuryApr 22, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT TKA, THE MALE PATIENT WAS SUFFERING FROM LAXITY AND PAIN. PATIENT HAD A REVISION SURGERY AN EARLY GRANULOMA ON PE SYNOVECTOMY WAS PERFORMED, LINER PE CHANGED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Granuloma; Implant Pain; Joint Laxity; Synovitis

  MAUDE report 19160079 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 70 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN JANUARY 2021, RETURNED TO THE SURGEON WITH PAIN AND SWELLING. RECENT X-RAYS REVEALED A SIGNIFICANT ASYMMETRY BETWEEN THE IMAGE TAKEN ON THE RIGHT SIDE IN 2021 AND THE ONE TAKEN ON THE LEFT SIDE LAST WEEK. CURRENTLY, THE PATIENT IS ON THE WAITING LIST FOR A REVISION AND IS HOPEFUL THAT ONLY THE INSERT WILL NEED TO BE REPLACED. THE SURGEON, FOLLOWING TWO ISSUES OF THE SAME NATURE OCCURRING IN A SHORT PERIOD, WANTS TO INVESTIGATE THE CAUSES LEADING TO THE PREMATURE WEAR OF THE POLYETHYLENE. X-RAYS WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 18735780 ↗
• InjuryJan 5, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) PT 2018. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(6). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT

  Patient problems: Insufficient Information

  MAUDE report 18455324 ↗
• InjuryDec 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2020. APPROXIMATELY 2 YEARS AND 9 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: RK POLYETHYLENE WEAR AND OSTEOLYSIS WITH LOOSENING THE POLYETHYLENE COMPONENT WAS REMOVED AND NOTED TO HAVE MODERATE WEAR MORE THAN EXPECTED FOR THE AGE OF IMPLANT. IT WAS ALSO NOTED TO HAVE SIGNIFICANT SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR. A SYNOVECTOMY WAS PERFORMED IN ALL COMPARTMENTS TO REMOVE THE AFFECTED TISSUE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 18312252 ↗
• InjuryJun 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2013. THEY HAD LEFT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 9 YEARS 11 MONTHS AFTER THEIR INITIAL PROCEDURE. THE PATIENT PRESENTED WITH MODERATE EFFUSION WITH SIGNIFICANT JOINT LAXITY. THERE WAS FOUND TO BE DELAMINATION OF THE POLYETHYLENE BUT NO EVIDENCE OF PROSTHESIS LOOSENING. THERE WAS FEMORAL DEBONDING. THERE WAS OSTEOLYSIS IN THE MEDIAL TIBIA. THE PATELLA WAS FOUND TO BE WELL FIXED AND LEFT IN PLACE. 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.

  Patient problems: Failure of Implant

  MAUDE report 17121195 ↗
• InjuryMay 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THE PATIENT HAD A LEFT KNEE REPLACEMENT (B)(6) 2013. APPROXIMATELY 9 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION DUE TO ACCELERATED AND PREVENTABLE WEAR. 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: Failure of Implant

  MAUDE report 16861954 ↗