BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 7110703 · Received December 12, 2017

    Report

    Report Number
    0001825034-2017-10971
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    January 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE DEVICE IS NO LONGER RELATED TO THE EVENT AND NO ISSUE HAS BEEN IDENTIFIED. THIS REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 10971, 0001825034 - 2017 - 10972, 0001825034 - 2017 - 10973, 0001825034 - 2017 - 10974. CONCOMITANT MEDICAL PRODUCTS: 139256 M2A-MAGNUM 42-50 TPR INSRT STD LOT 961970, 157450 M2A-MAGNUM MOD HD SZ 50MM LOT 760080, US15 7856 M2A-MAGNUM PF CUP 56ODX50ID LOT 869960, 11-104114 MLRY-HD POR FMRL 14X175MM LOT 256700. REPORT SOURCE FOREIGN. THE EVENT OCCURRED IN (B)(6) . THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND IS NOW EXPERIENCING A HERNIA (PATIENT SAID IS RELATED TO DEVICE). WHEN SITTING HE GETS PAIN DOWN THE LEG, THE SURGEON TOLD HIM IT IS THE SWELLING INSIDE HIS LEG PRESSING ON HIS SCIATIC NERVE. HE CAN ONLY WALK SHORT DISTANCES AND HE LIMPS. FEELS LIKE A TOOTH ACHE IN HIS HIP. WHEN SLEEPING AT NIGHT HIS LEG SWELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887561 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 961970

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other