BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 7010483 · Received November 8, 2017

    Report

    Report Number
    0001825034-2017-10072
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    August 12, 2015
    Report Date
    November 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - M2A-MAGNUM 52-60 MM TPR INSRT-3 CATALOG 139266 LOT 425280, ECHO POR FMRL NC 15 X 155 MM CATALOG 192015 LOT 433830, M2A-MAGNUM PF CUP 58ODX52ID CATALOG US157858 LOT 894980. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04946. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT AN UNKNOWN HIP REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE ELEVATED METAL ION LEVELS, PELVIC RING FRACTURE, AND PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. MEDICAL RECORDS STATE THE INDICATION FOR REVISION WAS SEVERE DESTRUCTION OF THE PELVIC BONE AND THE SURROUNDING MUSCULATURE. THERE WERE NUMEROUS LYMPHOCITES AND LEUKOCYTES THROUGHOUT THE TISSUES WHICH IS CONSISTENT WITH ASEPTIC, LYMPHOCYTE-DOMINATED VASCULITIS-ASSOCIATED LESION (ALVAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789084 M2A-MAGNUM MOD HD SZ 52MM KNEE, PROSTHESIS KWA ZIMMER BIOMET, INC. 634940

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R UNKNOWN M2A CUP| UNKNOWN STEM