BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 631802 · Received August 22, 2005

    Report

    Report Number
    631802
    Event Type
    Malfunction
    Date Received
    August 22, 2005
    Date of Event
    July 20, 2005
    Report Date
    August 11, 2005
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LINER OF HIP PROSTHETIC DEVICE CRACKED, RESULTING IN DISSOCIATION OF HIP JOINT AND THE NEED FOR SUBSEQUENT EXPLANTATION/REPLACEMENT. CORRECT HEAD COMPONENT WAS USED DURING INITIAL IMPLANTATION. LOT NO. 172350. MFR'S REP PRESENT DURING EXPLANTATION PROCEDURE AND TOOK DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET M2A RINGLOC ACETABULAR LINER JDI BIOMET, INC. 10 DEGREE SIZE 22 041580

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other