BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SIZE 42MM

    MDR report key: 6407806 · Received March 15, 2017

    Report

    Report Number
    3002806535-2017-00133
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    May 31, 2012
    Report Date
    March 15, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) # - (B)(4). CONCOMITANT MEDICAL PRODUCTS - BI-METRIC FEMORAL STEM, CATALOG#: 162312, LOT#: 1463315. RECAP/MAGNUM ACETABULAR CUP, CATALOG#: 157848, LOT#: 1413359. MAGNUM TAPER ADAPTER, CATALOG#: 139258, LOT#: 1416088. REPORT SOURCE - FOREIGN: EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. 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: 3002806535-2012-00373, 3002806535-2017-00133.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO PAIN, SWELLING, PSEUDOTUMOR FORMATION AND ELEVATED METAL ION LEVELS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189923 M2A-MAGNUM MODULAR HEAD SIZE 42MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1409832

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R