BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 14016048 · Received April 5, 2022

    Report

    Report Number
    0001825034-2022-00820
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    January 31, 2018
    Report Date
    May 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONE M2A-MAGNUM MOD HD SZ 44MM WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE IS SOME SCUFFING ON THE OUTSIDE RADIUS OF THE DEVICE WITH NO VISIBLE DAMAGE TO THE FACE. THERE IS NO VISIBLE DEBRIS INSIDE OF THE TAPER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A TAPER (CAT. NO. 139256, LOT NO. 891010), M2A PF CUP (CAT. NO. US157850, LOT NO. 055720), MALLORY/HEAD FEMORAL STEM (CAT. NO. 11-104109, LOT NO. 168570), GPS PLATELET CONCENTRATION SEPARATION KIT (CAT. NO. 800-1003A, LOT NO. 001471). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001825034-2022-00821, 0001825034-2022-00822, 0001825034-2022-00824.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 8 YEARS POST-IMPLANTATION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812749 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 637620

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H