BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 2281579 · Received October 4, 2011

    Report

    Report Number
    MW5022508
    Event Type
    Malfunction
    Date Received
    October 4, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 22, 2011
    Manufacturer
    BIOMET
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, THE PT EXPERIENCED PAIN AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTOR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS ACETABULAR CUP JDI BIOMET US157856 310020
    2 BIOMET ORTHOPEDICS MODULAR HEAD LZO BIOMET 157450 503950
    3 BIOMET ORTHOPEDICS TAPER ADAPTOR JDI BIOMET 139252 871680

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR