BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 14305653 · Received May 6, 2022

    Report

    Report Number
    0001825034-2022-01153
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    December 13, 2017
    Report Date
    May 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K062995
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 157442 LOT# 831010 M2A-MAGNUM MOD HD, CAT# 139254 LOT# 000880 M2A-MAGNUM 42-50MM, CAT# 11-104111 LOT# 814590 MLRY-HD POR FMRL. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DEVICES REMAIN ASSEMBLED UPON RECEIPT. VISUAL INSPECTION FOUND SCRATCHING ON THE EXPOSED SURFACE OF THE INSERT. THE TAPER IS ETCHED -3. DARK DEBRIS AND SCUFFING ARE PRESENT INSIDE THE TAPER OF THE INSERT. SCRATCHING WAS OBSERVED ON THE OUTSIDE OF THE HEAD IN MULTIPLE LOCATIONS. THE HEAD IS ETCHED 42. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10510, 0001825034-2018-10508, 0001825034-2018-11559.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY 10 YEARS POST INITIAL SURGERY FOR ONGOING PAIN, DISCOMFORT, MILD METALOSIS, ELEVATED IONS, AND MILD TRUNNIONOSIS WITH COLLECTED FLUID AROUND THE HIP. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436827 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 724930

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R