BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD 2HL SHL 41/56MM

    MDR report key: 7292259 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01039
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    April 14, 2015
    Report Date
    March 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: 11-163688, 32MM M2A HI CARBON HD STD NK, 161400; 11-163688, 32MM M2A HI CARBON HD STD NK, 161400; 103533, TI LOW PROFILE SCREW 6.5X30MM, 968160; X180311, BI-METRIC/X POR NC 11X135, 139960. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01038, 0001825034 - 2018 - 01037, 0001825034 - 2018 - 01040, 0001825034 - 2018 - 01041.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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'S HIP HAS BEEN REVISED APPROXIMATELY NINE YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS BEEN INDICATED FOR TOTAL HIP ARTHROPLASTY REVISION APPROXIMATELY TWELVE (12) YEARS POST-IMPLANTATION DUE TO PSEUDOTUMOR. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137095 M2A-T M/H RAD 2HL SHL 41/56MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 916190

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R