BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM

    MDR report key: 18326851 · Received December 14, 2023

    Report

    Report Number
    1038671-2023-02978
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    December 20, 2022
    Report Date
    December 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173492
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3616104 200-03-29 - ONE PEG PATELLA 29MM. 132891 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS. A20159209 620-12-02 - ACCELERATE PRP 60 ML & ACD-A. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 6 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: POLYETHYLENE FAILURE. THERE WAS A VAGUS CUTE IN THE FEMUR AND THEREFORE THEY REMOVED THE POLY. THERE WAS SIGNIFICANT OSTEOLYSIS. THEY COULD SEE WAVE IN THE FLUID AND THE SYNOVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327417 LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173492

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention SEE H10