BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS M2A MAGNUM

    MDR report key: 12787165 · Received November 9, 2021

    Report

    Report Number
    MW5105234
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    January 1, 2011
    Report Date
    November 5, 2021
    Manufacturer
    BIOMET INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY MOTHER HAD A HIP REPLACEMENT IN 2006. THE MANUFACTURER OF THE HIP IS BIOMET ORTHOPEDICS INC. (B)(4). GOING FORWARD SHE HAS EXPERIENCED SEVERE BURNING, PAIN AND MASSIVE SWELLING DUE TO THE METAL ON METAL HIP THAT IS CAUSING SWELLING OF HER JOINTS, CONTINUALLY GOING TO ORTHOPEDIC SURGEON TO HAVE HER HIP/GROIN AREA ASPIRATED TO REMOVE THE METAL DEBRIS/BLOOD COLLECTION. SHE IS CONSTANT PAIN, HER QUALITY OF LIFE HAS BEEN GREATLY COMPROMISED. THE SURGEON RECENTLY TOLD HER AFTER HAVING RECENT SURGERY TO PARTIALLY REMOVE A MASSIVE TUMOR THAT IS BEING CAUSED BY THE HIP THAT HER ANATOMY IS BEING EATEN AWAY FROM THE METAL. THE BIOMET METAL ON METAL HAS BEEN DETRIMENTAL TO MY MOTHER. THE DATE OF THE HIP REPLACEMENT IS (B)(6) 2006. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677597 BIOMET ORTHOPEDICS M2A MAGNUM PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA BIOMET INC. BIOMET REF US157852/REF X180314

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Life Threatening| S| H| O INDAPAMIDE| BABY ASPIRIN| CYMBALTA| LISINOPRIL| VITAMIN D