Optetrak Logic 02-012-44-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862173614), received between Mar 6, 2023 and Nov 25, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 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.

• InjuryNov 25, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED AND THE PS FEMORAL, LOGIC FIT TRAY, AND SIZE 13MM PSC POLY WERE ALL REMOVED DUE TO DELAMINATION OF THE POLYETHYLENE COMPONENT. SURROUNDING AND AFFECTED TISSUE WAS EXCISED AND A CC STEMMED FEMORAL COMPONENT WAS IMPLANTED, ALONG WITH A STEMMED TIBIAL TRAY AND CC SIZE 21 POLY. IT IS A POSSIBILITY THIS PATIENT WAS AFFECTED BY THE RECALL. 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: Pain; Swelling/ Edema

  MAUDE report 20776113 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 45 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: Insufficient Information

  MAUDE report 20179434 ↗
• InjuryJun 5, 2024Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, SWELLING, LIMITED RANGE OF MOTION, STIFFNESS, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, AND BONE LOSS. 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; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 19470695 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 116 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAD A PLANNED REVISION PROCEDURE DUE TO PROSTHESIS WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19331526 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 116 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAD A PLANNED REVISION PROCEDURE FOR PROSTHESIS WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19331248 ↗
• InjuryJan 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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 ON (B)(6) 2023. DIAGNOSIS: PAIN. THE TIBIAL POLYETHYLENE COMPONENT WAS LOOSE WITHIN THE TRAY AND NOTED TO HAVE FAILED WITH NO LOCKING IN PLACE. THERE WAS EXTENSIVE OSTEOLYSIS. THERE WAS A ROBUST FUSION. THERE WAS EXTENSIVE SYNOVITIS AROUND THE KNEE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Inflammation; Joint effusion; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 18562177 ↗
• InjuryJan 11, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 4 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT 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. REVISION OP REPORT ON (B)(6) 2022 DIAGNOSIS: FAILED BILATERAL TOTAL KNEE REPLACEMENT SECONDARY TO BEARING SURFACE WEAR AT SURGERY THEY FOUND EXUBERANT SYNOVITIS, SYNOVIAL EXPANSION AND FOREIGN BODY TYPE SYNOVIAL REACTION. THE RIGHT SIDED TIBIAL POLYETHYLENE SHOWED SEVERE BILATERAL PLATEAU WEAR WITH GROSS DEFORMITY AND LOSS OF SUBSTANCE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. 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 KN

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

  MAUDE report 18490862 ↗
• InjurySep 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2020. APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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 ON (B)(6) 2023: DIAGNOSIS: FAILED RIGHT KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE. FINDINGS: FOUND EXUBERANT SYNOVITIS, GROSS SYNOVIAL EXPANSION, NO EVIDENCE OF COMPONENT LOOSENING AND SEVERE DELAMINATION OF THE TIBIAL POLYETHYLENE ARTICULAR SURFACE.

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

  MAUDE report 17697731 ↗
• InjuryJun 7, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION (B)(6) 2023. 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: Failure of Implant; Insufficient Information

  MAUDE report 17080632 ↗
• InjuryApr 28, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT HAD A REVISION OF FEMUR AND POLY WITH STEM/AUGMENTS. PATIENT WAS REVISED TO AN EXACTECH CC FEMUR, STEM AUGMENTS AND CC INSERT. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTO/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO PATIENT'S LAWYER REQUESTED IMPLANTS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 16833877 ↗
• InjuryMar 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DEPARTMENT, A PATIENT UNDERWENT INITIAL LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2015. HE WAS IMPLANTED WITH AN OPTETRAK DEVICE. ON (B)(6) 2022, THE PATIENT UNDERWENT LEFT KNEE REVISION SURGERY, APPROXIMATELY 7 YEARS 8 MONTHS POST INITIAL PROCEDURE, TO REMOVE THE FAILED POLYETHYLENE LINER DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE TIBIAL INSERT. REVISION OP REPORT ((B)(6) 2022) DIAGNOSIS: LEFT KNEE OSTEOLYSIS DUE TO POLYETHYLENE WEAR. FINDINGS: GLOBAL INSTABILITY, LARGE EFFUSION WITHOUT GROSS EVIDENCE OF INFECTION. SYNOVITIS CONSISTENT WITH POLY WEAR. LOOSENING PATELLAR COMPONENT. FEMORAL COMPONENT NOT GROSSLY LOOSE HOWEVER DEBONED FROM CEMENT MANTLE AND REMOVED WITH BONE TAMP WITH NO ATTACHED CEMENT ON BACK SIDE OF IMPLANT. TIBIA WELL FIXED. MASSIVE OSTEOLYSIS TIBIA WORSE MEDIAL AND POSTEROMEDIALLY WITH UNCONTAINED DEFECT. AORI 2B BONE LOSS TIBIA AND FEMUR. THERE WERE NO COMPLICATIONS. A SURGICAL DEFRIEF WAS PERFORMED. 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

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16487667 ↗