BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD

    MDR report key: 9546991 · Received January 3, 2020

    Report

    Report Number
    0001825034-2020-00025
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 9, 2019
    Report Date
    April 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER, AS WELL AS THE X-RAYS SHOW NO EVIDENCE OF LOOSENING, MALFUNCTION OF THE IMPLANT, CORROSION, OR OSTEOLYSIS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TAPERLOC POR LAT FMRL 11X142 CAT# 11-103205 LOT# 188920, M2A-MAGNUM PF CUP 54ODX48ID CAT# US157854 LOT# 921250, M2A-MAGNUM 42-50MM TPR INSRT-6 CAT# 139252 LOT# 060800. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -00023, 0001825034 -2020 -00024, 0001825034 -2020 -00026.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY 10 YEARS LATER DUE TO PAIN AND ELEVATED METAL ION LEVELS. THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5856 M2A-MAGNUM MODULAR HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 721120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R