Optetrak Logic 02-012-51-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862230324), received between Jun 6, 2023 and Jul 29, 2025 — classified as 10 injuries, 1 malfunction.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  THE DEVICE FAILED AS INTENDED AS THE POLY WORE OUT.

  Patient problems: Insufficient Information

  MAUDE report 22660907 ↗
• MalfunctionMay 6, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE FOR A 73 YO FEMALE PATIENT, A WRONG INSERT WAS IMPLANTED. THE IN-SITU IMPLANTS WERE A SIZE 3 FEMORAL COMPONENT AND A SIZE 3F/2T TIBIAL PLATE. AS A RESULT, THE TIBIAL INSERT REQUIRED WAS A SIZE 3, TO MATCH BOTH FEMUR AND TIBIAL LOCKING MECHANISM; HOWEVER, A SIZE 2 INSERT WAS IMPLANTED. THE SURGEON WAS NOTIFIED THAT A REVISION PROCEDURE MAY BE RECOMMENDED. UNKNOWN IF A REVISION HAS BEEN SCHEDULED AT THIS TIME. NO PATIENT IMPACT REPORTED. THIS IS 1 OF 3 EVENTS FOR THIS PATIENT. SEE MDR# 1038671-2025-01881 FOR LEFT KNEE REVISION AND MDR# 1038671-2023-01420 FOR RIGHT KNEE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21971053 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 60 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST OP. FEMUR AND TIBIA WERE REVISED DUE TO OSTEO-LYSIS AND FEMORAL LOOSENING. SURGEON REMOVED ALL EXACTECH DEVICES AND PUT ANOTHER COMPANIES PRODUCT IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED AT THE HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 20136700 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19500410 ↗
• InjuryFeb 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 5 YEARS AND 9 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 18759599 ↗
• InjuryNov 7, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL LEFT TKA, THE 64 Y/O FEMALE PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLY SWAP. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS & X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

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

  MAUDE report 18083868 ↗
• InjuryOct 10, 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) 2015. APPROXIMATELY 7 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE PAIN, SWELLING, INSTABILITY, FALLS, WEAKNESS, AND LIMITED MOBILITY. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), 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 APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

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

  MAUDE report 17903614 ↗
• InjuryJun 28, 2023Naturally Worn; Patient Device Interaction Problem; Naturally Worn; Patient Device Interaction Problem

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL LEFT TKA, THIS 70 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. PATELLA AND LINER WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING - DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17215636 ↗
• InjuryJun 20, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT TKA, THE 72 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT'S LINER, PATELLA AND FEMORAL COMPONENT WERE EXCHANGED TO A PS TOTAL KNEE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 17160081 ↗
• InjuryJun 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN APPROXIMATELY 6 YEARS, 2 MONTHS LATER, ON (B)(6) 2023, THEY EXPERIENCED A REVISION SURGERY. REVISION OPERATIVE REPORT OF (B)(6) 2023. POSTOPERATIVE DIAGNOSIS: PAINFUL RIGHT KNEE ARTHROPLASTY. PATIENT PRESENTED WITH PAIN, INSTABILITY THIS WAS WORSENING OVER TIME. CLINICAL EXAMINATION IMAGING WAS CONSISTENT WITH POSSIBLE SYMPTOMATIC POLYETHYLENE WEAR. THERE WAS NO EVIDENCE OF PURULENCE. THERE WAS A SMALL EFFUSION, THERE WAS WHITE SYNOVITIS INVOLVING THE KNEE WHICH CAN BE SEEN WITH POLY WEAR. NO LOOSENING/INSTABILITY OF THE FEMORAL OR TIBIAL COMPONENTS. THERE WAS A SMALL AMOUNT OF OSTEOLYSIS EVIDENT ALONG THE LATERAL MARGIN OF THE FEMUR. THERE WAS SIGNIFICANT WEAR INVOLVING THE ANTERIOR ASPECT OF THE PATELLA. THERE WAS ENOUGH WEAR OF THE PATELLA THAT IT COULD POTENTIALLY CAUSE SOME PARTICLE DISEASE. PATELLA COMPONENT WAS REVISED. STERILE DRESSING WAS APPLIED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY INSTABLE CONDITION. PATIENT WILL FOLLOW UP WITH ORTHOPEDIC CLINIC 2 WEEKS POST OP. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 17109289 ↗
• InjuryJun 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT'S LINER WAS REVISED TO AN EXACTECH DEVICE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17068174 ↗