BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 7110707 · Received December 12, 2017

    Report

    Report Number
    0001825034-2017-10973
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    March 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION

    Additional Manufacturer Narrative · 1

    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. 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.

    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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY DUE TO UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING A HERNIA, PAIN, AND SWELLING. AFTER RECEIPT OF LAB RESULTS IT IS NOTED THAT THERE ARE ELEVATED COBALT AND CHROMIUM LEVELS. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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
    887562 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 869960

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other