Optetrak Logic 02-012-51-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862230362), received between Mar 29, 2022 and Dec 18, 2025 — 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.

• InjuryDec 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND WEAR OF THE POLYETHYLENE INSERT. SURGEON REPLACED THE INSERT AFTER REMOVAL OF POLY DEBRIS IMBEDDED IN THE TISSUES. NO OTHER REPORTED ISSUES WITH THE SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pain

  MAUDE report 23840006 ↗
• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 2 YEARS 10 MONTHS POST INITIAL RIGHT KNEE IMPLANTATION; IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AND POLY WEAR. THE FEMUR AND LINER WERE REVISED TO A LOGIC PS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. NO DEVICE RETURNS FOR ANALYSIS AVAILABLE AS THE DEVICES WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20844010 ↗
• InjuryOct 21, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 5 MONTHS POST LEFT TOTAL KNEE ARTHROPLASTY (TKA), REVISION OF THE PROSTHESIS WAS PERFORMED DUE TO WEAR ON THE PATELLA AND TIBIAL INSERT AS WELL AS THE FEMUR ¿DEBONDED¿ FROM THE CEMENT. EVERYTHING WAS REMOVED AND REPLACED WITH A COMPETITOR PROSTHETIC. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE AND NO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20495957 ↗
• InjuryMar 18, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 2 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AND POLY WEAR. THE FEMUR AND LINER WERE REVISED TO A LOGIC PS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. NO DEVICE RETURNS FOR ANALYSIS AVAILABLE AS THE DEVICES WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18927361 ↗
• InjuryJan 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN MONTHS POST RIGHT TKA REVISION, THE 68 Y/O FEMALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AS WELL AS POLY WEAR AND DELAMINATION. THIS POLY WAS IN A CONFORMING BAG AND HAS ONLY BEEN IN SINCE (B)(6) 2023 BUT IT ALREADY SHOWED SIGNIFICANT DAMAGE. THE WEAR CHARACTERISTICS ARE THE SAME AS THE OTHER AFFECTED POLY¿S PITTING AND WEAR MARKS. ALL COMPONENTS WERE REMOVED. PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18477832 ↗
• InjuryOct 10, 2023Naturally 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)2014. APPROXIMATELY 7 YEARS AND 10 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 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) COUNTY WITH MASTER CASE NO. (B)(4). 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 RES

  Patient problems: Insufficient Information

  MAUDE report 17905254 ↗
• InjurySep 13, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL RIGHT TKA, THE 64 Y/O FEMALE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A TKA REVISION FOR POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA IMPLANT SWAP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

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

  MAUDE report 17737330 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP INITIAL RIGHT TKA, THIS 67 Y/O FEMALE PATIENT WAS REVISED. PATIENT PRESENTED WITH SWELLING AND REDUCED ROM. DAIR PROCEDURE AND LATERAL FACETECTOMY PERFORMED. LINER WAS EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS & X-RAYS ATTACHED. PRODUCT NOT RETURNING - SENT TO RPH FOR ANALYSIS.

  Patient problems: Failure of Implant

  MAUDE report 17682006 ↗
• InjuryApr 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL RIGHT TKA, THIS 84 Y/O FEMALE PATIENT WAS REVISED DUE TO THE POLY DELAMINATING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - DISPOSED. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS.

  Patient problems: Arthritis; Failure of Implant; Fever; Pain; Sepsis; Swelling/ Edema; Syncope/Fainting

  MAUDE report 16783912 ↗
• InjuryMar 29, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY SEVEN YEARS POST INITIAL TKA, THIS (B)(6) FEMALE PATIENT IS EXPECTED TO HAVE A REVISION SURGERY ON (B)(6) 2022 IN ORDER TO REPLACE THE ERODED EXACTECH ARTIFICIAL CARTILAGE (PLASTIC TIBIAL INSERT). THE PATIENT WAS INITIALLY DIAGNOSED WITH OSTEOPENIA AND SINCE HER INITIAL SURGERY EXPERIENCED NUMEROUS SYMPTOMS, INCLUDING PAIN, SWELLING, DIFFICULTY WALKING, AND WAKING AT NIGHT DUE TO KNEE PAIN. THESE SYMPTOMS STARTED A COUPLE OF YEARS AFTER THE SURGERY. THE SYMPTOMS HAVE SLOWLY AND STEADILY WORSENED. PATIENT MENTIONED THAT AT FIRST, "SHE FOUND THAT SHE COULD NOT WALK ON PAVEMENT WITHOUT PAIN AND SWELLING THAT LASTED AFTERWARD FOR HOURS. THEN, SHE BEGAN TO HAVE THE SAME SYMPTOMS AFTER WALKING ON SMOOTH DIRT PATHS IN THE WOODS".

  Patient problems: Failure of Implant

  MAUDE report 13944807 ↗