Optetrak Logic 02-012-44-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862173607), received between Mar 22, 2023 and Apr 14, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Naturally Worn” (15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD A TKA, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SUFFERING FROM PATELLAR COMPONENT LOOSENING & POLYETHYLENE WEAR¿INDUCED SYNOVITIS. A SYNOVECTOMY WAS PERFORMED. THE PATELLA & TIBIAL INSERT WERE EXCHANGED. NO X-RAYS OR IMAGING WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Synovitis

  MAUDE report 24880202 ↗
• InjuryMay 27, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. THE PATIENT WAS REVISED APPROXIMATELY 4 YEARS 3 MONTHS POST OPERATION. SUBSEQUENTLY, PATIENT EXPERIENCED JOINT EFFUSION WITHOUT TENSION, COLD KNEE, AND A SURGICAL WOUND WITHOUT ABNORMALITIES. PATIENT HAD PAIN RELATED TO THE TIBIAL COMPONENT WITH MEDIAL INSTABILITY BUT HAD FULL RANGE OF MOTION.

  Patient problems: Granuloma; Inadequate Osseointegration; Joint Laxity; Joint effusion; Osteolysis; Pain

  MAUDE report 22088243 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 85 MONTHS AFTER A RIGHT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543610 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PATIENT MOBILITY AND QUALITY OF LIFE. PATIENT CURRENTLY SCHEDULED FOR A REVISION SURGERY IN (B)(6) 2024. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K110547.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20152325 ↗
• InjuryJul 26, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  LEGAL CASE ¿ USA BULK LEGAL EMAIL (440). PATIENT ID: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 127 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR UNKNOWN ISSUES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 19844606 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, MOTION RESTRICTION, DIFFICULTY WITH AMBULATION, DIFFICULTY PERFORMING SIMPLE ACTIVITIES OF DAILY LIVING. 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; Discomfort; Emotional Changes; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 19804510 ↗
• InjuryJun 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 3 YEARS, 3 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, IMPLANT-INTERFACE DEBONDING, GENICULATE ARTERY EMBOLIZATION, PATELLAR LATERAL FACETECTOMY. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19533489 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 135 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: Failure of Implant; Joint Laxity; Osteolysis

  MAUDE report 19364525 ↗
• InjuryMay 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, JOINT EFFUSION, JOINT LAXITY, AND OSTEOLYSIS. 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; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 19351470 ↗
• InjuryApr 29, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2014 AND THEN WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, INSTABILITY, BONY DEFECTS, AND DEVICE FAILURE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

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

  MAUDE report 19208815 ↗
• InjuryMar 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 76 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. A SYNOVECTOMY FOUND TRACES OF OSTEOLYSIS DUE TO POLY WEAR. THE POLY LINER AND PATELLA WERE EXCHANGED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE EVENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 18833663 ↗
• InjurySep 18, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 2 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING. 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APP

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 17765212 ↗
• InjurySep 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2013. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 9 YEARS 6 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING, MASSIVE OSTEOLYSIS, POLYETHYLENE 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.

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 17711236 ↗
• InjuryJun 7, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE 74 Y/O FEMALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6)2022. 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 30 SEPT 2022: DIAGNOSIS: POLYETHYLENE WEAR AND LOOSENING FEMORAL COMPONENT. FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS FOUND TO BE A WELL-FIXED TIBIAL COMPONENT. THERE WAS VISIBLE EVIDENCE OF POLYETHYLENE WEAR WITH THE TIBIAL POLYETHYLENE, AS WELL AS THE PATELLAR BUTTON POLYETHYLENE. THE POLY INSERT AND THE PATELLAR BUTTON WERE REMOVED. THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE FROM THE CEMENT MANTLE ON THE DISTAL FEMUR AND WAS REVISED WITH A FULLY-CEMENTED STEMMED COMPONENT. ACE WRAP USED. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant; Scar Tissue

  MAUDE report 17080334 ↗
• InjuryApr 18, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  PER A REPORT FROM THE LEGAL DEPARTMENT A 69 Y/O MALE PATIENT HAD AN INITIAL LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS 8 MONTHS LATER, THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. OP REPOT (B)(6) 2022. POSTOPERATIVE DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC LEFT KNEE JOINT. A COMPRESSIVE BULKY DRESSING WAS PLACED. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO RECOVERY UNIT. 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; Osteolysis; Scar Tissue

  MAUDE report 16762147 ↗
• InjuryMar 22, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  THE REVISION REPORTED MAY HAVE BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESIS, WHICH LED TO INSTABILITY.

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 16591318 ↗