Optetrak Logic 02-012-44-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862173508), received between Nov 9, 2020 and Apr 21, 2025 — 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.

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.

• InjuryApr 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE AND FOUND SEVERE OSTEOLYSIS PRESENT. THE PATELLA EXHIBITED MEDIAL TO LATERAL WEAR ALONG THE TRACKING PATH. THE TIBIAL INSERT HAD MILD MEDIAL WEAR. ADDITIONAL WEAR ON THE POSTERIOR POST FOUND. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE PATELLA AND PSC INSERT WERE REPLACED WITH SAME SIZE/TYPE COMPONENT. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY ARE BEING RETAINED BY THE HOSPITAL FOR ANALYSIS. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Osteolysis

  MAUDE report 21877160 ↗
• InjuryJan 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 68 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISCOMFORT, DISTRESS, PAIN, SCAR TISSUE, SYNOVITIS, AND OSTEOLYSIS. INITIAL SURGERY AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21197569 ↗
• InjurySep 30, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA. (B)(4) LK REV 1 IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 66 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAINFUL AND UNSTABLE LEFT KNEE; EXTENSIVE SYNOVITIS, OSTEOLYSIS ON FEMUR AND PATELLA, ASEPTIC LOOSENING OF FEMORAL, WEAR OF THE LINER WITH DELAMINATION, WEAR OF THE PATELLA. 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. THE SERIAL NUMBER: (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20337233 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 75 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: Aseptic loosening; Cyst(s); Joint effusion; Synovitis

  MAUDE report 20136469 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 122 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LARGE EFFUSION, SYMPTOMATIC POLYETHYLENE WEAR, OXIDATION. 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; Insufficient Information; Joint effusion; Pain

  MAUDE report 19508790 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 10 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19463231 ↗
• InjuryAug 30, 2023Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2016. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 6 YEARS 5 MONTHS POST PRIMARY SURGERY. REVISION OP REPORT STATED THAT THE IMPLANTS WERE GROSSLY UNSTABLE IN THE AP AND ML DIRECTION. THE FEMORAL CONE COMPONENT WAS DISSECTED AND EASILY REMOVED WITH A GENTLE TAP, THE IMPLANT SEPARATING AT THE CEMENT INTERFACE. 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; Implant Pain; Joint Laxity

  MAUDE report 17654653 ↗
• InjuryApr 24, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT IN (B)(6) 2018. APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER THE INITIAL SURGERY, THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 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: Ambulation or Postural Difficulties; Balance Problems; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16794382 ↗
• InjuryFeb 27, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6)2018. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 4 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: S/P RECALLED TKA WITH POLY WEAR, SYNOVITIS AND ASEPTIC LOOSENING OF FEMUR. THE PATELLAR BUTTON WAS FOUND TO BE INTACT BUT WITH SOME SURFACE WEAR. THE POLYETHYLENE WAS NOTED TO HAVE SOME DAMAGE THAT WAS NOT CLEARLY VISIBLE BUT COULD PALPATE DEFT. THE FEMORAL COMPONENT WAS NOTED TO HAVE COMPLETELY DEBONDED FROM ITS CEMENT MANTLE. THE CEMENT MANTLE WAS INTACT, AND WHEN IT WAS REMOVED, THERE WAS NOTED TO BE AORI TYPE IIB BONE LOSS, WORSE ON THE LATERAL COMPARED TO MEIAL SIDE, AND OSTEOLYSIS AFFECTING BOTH POSTERIOR CONDYLES. THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY INTACT, NOT LOOSE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 16450198 ↗
• InjuryNov 9, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO RANGE OF MOTION/STIFFNESS. INITIAL SURGERY DATE WAS (B)(6) 2012. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10808430 ↗