BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW

    MDR report key: 10301538 · Received July 21, 2020

    Report

    Report Number
    0001822565-2020-02619
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MRA
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00875705601 ¿ CONTINUUM CUP ¿ 61774203. 00877504002 ¿ BIOLOX DELTA HEAD ¿ 231975. 00885101240 ¿ NEUTRAL LINER ¿ UNKNOWN LOT NUMBER. REPORTED EVENT IS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS NOTING ACETABULAR COMPONENT SPINNING OUT OF POSITION AND A FRACTURED BONE SCREW. VISUAL REVIEW OF PHOTOGRAPHS IDENTIFIED THE FOLLOWING : THE PRODUCTS WERE COVERED IN BIODEBRIS. A FRAGMENT OF THE FRACTURED SCREW WAS PROTRUDING OUT OF ONE OF THE SCREW HOLES. DHR WAS UNABLE TO BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 02618.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO LOOSENING OF THE ACETUABULAR COMPONENT AND FRACTURE OF THE SCREW. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769859 BONE SCREW PROSTHESIS, HIP MRA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R