BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD

    MDR report key: 8754403 · Received July 2, 2019

    Report

    Report Number
    0001825034-2019-02864
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    April 1, 2019
    Report Date
    March 18, 2021
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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

    A M2A-MAGNUM MOD HD SZ 42MM, PART # 157442 FROM LOT 872620, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE HEAD TO BE ASSEMBLED WITH A TAPER INSERT UPON RECEIPT. THE OUTER RADIUS OF THE HEAD IS SCUFFED AND SCRATCHED. YELLOW DEBRIS IS PRESENT ON THE EXPOSED SURFACE AND CUTOUTS OF THE TAPER INSERT. A SMALL AMOUNT OF LIGHT COLORED DEBRIS WAS OBSERVED INSIDE THE TAPER OF THE INSERT. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: US157848, ITEM NAME: M2A-MAGNUM PF CUP 48ODX42ID, LOT #: 789250, ITEM NUMBER: 139254, ITEM NAME: M2A-MAGNUM 42-50MM TPR INSRT-3, LOT #: 872620, ITEM NUMBER: 11-104109, ITEM NAME: MLRY-HD POR FMRL 9X150MM, LOT #: 692820. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02865. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 10 YEARS POST-IMPLANTATION DUE TO A PSEUDOTUMOR, METALLIC DEBRIS AND HIP TISSUE AND BONE DAMAGE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548710 M2A-MAGNUM MOD HD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 872620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE