BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7999887 · Received October 24, 2018

    Report

    Report Number
    0001825034-2018-09913
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    November 13, 2017
    Report Date
    December 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157850, M2A MAGNUM CUP, 517710; 192508 ECHO BIMETRIC STEM, 850970; 139254, M2A MAG TAPER, 627930. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY REVISION APPROXIMATELY 6 YEARS POST OPERATIVELY DUE TO ELEVATED ION LEVELS. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: UNK ITEM#; UNKNOWN STEM; UNK LOT #, UNK ITEM#; UNKNOWN CUP; UNK LOT #. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY REVISION DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842122 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 658340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R