BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS/OSS 5CM TPR ADAPT W/OSS SC

    MDR report key: 12165321 · Received July 14, 2021

    Report

    Report Number
    0001825034-2021-02095
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: 2007. CONCOMITANT MEDICAL DEVICES: 150460 - OSS LETSON MOD PROX FMRL L 7CM - 809550; 150464 - OSS 3CM DIAPHYSEL SEGMENT - UNKNOWN; UNKNOWN - MAGNUM 52MM HEAD - UNKNOWN. VISUAL EXAMINATION OF THE PROVIDED PHOTOS CONFIRM THE TAPER ADAPTER FRACTURED. THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. X-RAYS WERE PROVIDED HOWEVER THEY WERE NOT SENT FOR FURTHER REVIEW AS THEY WOULD NOT ENHANCE THE INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 14 YEARS LATER DUE TO A FRACTURED TAPER ADAPTER. THE ONLY FAILED ITEM WAS THE COMPRESS ADAPTER TAPER. THERE WAS NO TRAUMA REPORTED. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063525 CPS/OSS 5CM TPR ADAPT W/OSS SC PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 196290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R