Optetrak Logic 02-012-51-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885862230560), received between Mar 29, 2022 and Feb 18, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Naturally Worn” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue

  MAUDE report 21398671 ↗
• InjuryOct 31, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING, OSTEOLYSIS AND POLY WEAR. EVERYTHING WAS REMOVED AND EXCHANGED TO A COMPETITOR'S PRODUCT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 20576766 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 YEARS 8 MONTHS POST OP. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT, EXCHANGED TO COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Insufficient Information

  MAUDE report 20204398 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLY WEAR DISEASE AND EXTENSIVE OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 20070736 ↗
• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 90 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, AND SYNOVITIS. 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; Implant Pain; Osteolysis; Pain; Synovitis

  MAUDE report 19475545 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA 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 RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE. LEFT KNEE WAS ALSO OPERATED IN (B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 19372152 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA 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 RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE. RIGHT KNEE WAS ALSO OPERATED ON CASE-(B)(4).

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 19369571 ↗
• InjuryMar 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO LOOSENING FROM PATELLA AND POLY WEAR. ALL COMPONENTS WERE REVISED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. 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: Aseptic loosening; Failure of Implant

  MAUDE report 18852932 ↗
• InjuryJan 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST INITIAL RIGHT TKA, THE 71 Y/O MALE PATIENT HAD A REVISION DUE TO POLY RECALL SCENARIO. THE POLY WAS DELAMINATED, BROKEN AND PARTICLES HAD IRRITATED SURROUNDING TISSUE. THE PATIENT WAS REVISED TO EXACTECH DEVICES. SURGEON IMPLANTED CC FEMORAL AND CC TIBIAL COMPONENTS AFTER CRC IMPLANTS WERE REMOVED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

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

  MAUDE report 18563538 ↗
• InjuryJan 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY OF AN OPTETRAK LOGIC ON (B)(6) 2019 AND THEN APPROXIMATELY 3 YEARS, 10 MONTHS LATER ON (B)(6) 2023 HAD A REVISION SURGICAL PROCEDURE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR 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 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; Pain

  MAUDE report 18434219 ↗
• InjuryDec 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN PREVIOUS REVISION ON (B)(6) 2023. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2023 DUE TO PATELLA WEAR AND POLY WEAR; THERE WAS NO CHANGE IN SIZING. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18290922 ↗
• InjuryNov 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMORAL LOOSENING. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE REVISED WITH NEW COMPONENTS. THERE WAS NO CHANGE IN SIZE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18187329 ↗
• InjuryAug 4, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TKA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR AND LOOSENING FEMUR. REVISED FROM CR TO PS. 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 17457433 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS IS THE 3RD REVISION FOR THIS PATIENT'S RIGHT KNEE. THE POLY LINER WAS EXCHANGED TWICE BEFORE DUE TO WEAR. AS MULTIPLE REVISION SURGERIES WERE DONE UNFORTUNATELY RISK INCREASES. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO INFECTION. A NEW FEMORAL COMPONENT AND LINER WERE IMPLANTED. CEMENT WAS UTILIZED FOR TIBIA AND PATELLA. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY / PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17368336 ↗
• InjuryJun 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL RIGHT TKA, THIS 75 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED AND USED OTHER COMPANY¿S PRODUCTS. NO PRODUCT DETAILS AVAILABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - DISPOSED AT THE HOSPITAL.

  Patient problems: Bone Fracture(s); Cyst(s); Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 17180573 ↗
• InjuryDec 28, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 61 YO MALE, INITIAL RIGHT KNEE IMPLANTED ON (B)(4) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THEY WERE REVISED DUE TO POLY WEAR AND PITTING BEING PRESENT ON THE BEARING SURFACE. THE FEMUR WAS REVISED DUE TO LOOSENING. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION.

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

  MAUDE report 16064495 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY FIVE YEARS POST INITIAL TKA, THIS MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14213235 ↗
• InjuryMar 29, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS MALE PATIENT HAD A REVISION DUE TO THE IMPLANT WAS ONE OF THE RECALLED POLYS. SURGEON REPLACED WORN POLY WITH A NEW POLY. THE POLY WAS SEVERELY DELAMINATED AND PITTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 13944568 ↗