BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM

    MDR report key: 17650228 · Received August 30, 2023

    Report

    Report Number
    1038671-2023-02094
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    March 1, 2023
    Report Date
    January 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173553
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORT NUMBERS: 1038671-2023-02094 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-02094 THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND PATELLAR LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 10 YEARS 3 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. THE PATIENT PRESENTED WITH RIGHT KNEE PAIN AND EFFUSION WITH POLYETHYLENE WEAR AND OSTEOLYSIS ON IMAGING. UPON REMOVAL, THE SURGEON NOTED THE POLYETHYLENE INSERT HAD SIGNIFICANT WEAR ON THE MEDIAL GREATER THAN LATERAL ARTICULAR SURFACE. THERE WERE SOME FREE SHEERED OFF PIECES OF POLYETHYLENE WITHIN THE JOINT AS WELL. THE FEMORAL COMPONENT WAS FOUND TO BE SIGNIFICANTLY LOOSE AND WAS EASILY REMOVED. THERE WAS NO CEMENT THAT REMAINED ON THE BACKSIDE OF THE IMPLANT. REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI 2B BONE LOSS FROM AREAS OF SIGNIFICANT OSTEOLYSIS, MOST NOTABLE AT THE POSTERIOR LATERAL CONDYLE. THE TIBIAL COMPONENT WAS FOUND TO HAVE SIGNIFICANT OSTEOLYSIS UNDERNEATH THE TRAY ON THE MEDIAL SIDE. WHILE DRILLING FOR THE BOSS OF THE TIBIA, THERE WAS NOTED TO BE A BREACH OF THE POSTERIOR CORTEX OF THE TIBIA. THE PATELLA WAS ALSO NOTED TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492389 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNK 10885862173553

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention