BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM RECAP CUP 46ODX40ID

    MDR report key: 8160658 · Received December 13, 2018

    Report

    Report Number
    3002806535-2018-01269
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 22, 2018
    Report Date
    January 28, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K062995
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE 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

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, DUE TO METALLOSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- M2A-MAGNUM MOD HD SZ 40MM, ITEM 157440, LOT 1120212, THERAPY DATE - (B)(6) 2018, MAG TPR ADPR TI 38-40/-2 12/14 ,ITEM 130824, LOT 112455, THERAPY DATE - (B)(6) 2018. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01270 AND 3002806535-2018-01271.

    Description of Event or Problem · 1

    REVISION DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002710 M2A-MAGNUM RECAP CUP 46ODX40ID HIP PROSTHESIS KWA BIOMET UK LTD. 817398

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R