BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM

    MDR report key: 6198346 · Received December 22, 2016

    Report

    Report Number
    0001825034-2016-05254
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 3, 2016
    Report Date
    July 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 010000704 3813949 G7 BONEMASTER LTD ACET SHL 54F. A 010000936, 3013817 G7, HIGH WALL E1 LINER 36MM F. A 11-363662, 684190, 36MM COCR MOD HD STD. UDI - (B)(4). PMA 510(K): - THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMLIAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101086.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF RADIOGRAPHS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT FALL. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL 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 RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FELL THE NIGHT OF THE PROCEDURE, WHICH RESULTED IN A FEMORAL FRACTURE. THE PATIENT WAS REVISED DUE TO INSTABILITY OF THE STEM CAUSED BY PERIPROSTHETIC FEMORAL FRACTURE. THE HEAD AND STEM WERE REVISED. THE FALL WAS REPORTED TO BE UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848553 TAPERLOC FEMORAL STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 2431498

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R