BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 1960966 · Received January 11, 2011

    Report

    Report Number
    MW5018959
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    May 11, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BIOMET
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A THR ON (B)(6) 2010, AT (B)(6) MEDICAL CENTER IN (B)(6), BY SURGEON (B)(6) OF (B)(6) ABOUT 7 WEEKS S/P IMPLANT, I STARTED EXPERIENCING MUCH PAIN IN THE HIP AND NUMEROUS SIGNS & SX OF INFECTION. TWO CONSULTING ORTHOPEDIC SURGEONS, DR (B)(6), AND DR (B)(6), BOTH FEEL I HAVE A DEEP PROSTHETIC INFECTION THAT MAY GO DORMANT & THEN REVIVE NECESSITATING EMERGENCY REVISION OR, THE IMPLANT IS METAL ON METAL CAUSING PROBLEMS THAT WILL RESULT IN RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS HIP IMPLANT COMPONENTS JDI BIOMET 212 560
    2 BIOMET ORTHOPEDICS HIP IMPLANT COMPONENTS JDI BIOMET 004 080
    3 BIOMET ORTHOPEDICS HIP IMPLANT COMPONENTS JDI BIOMET 182 950
    4 BIOMET ORTHOPEDICS HIP IMPLANT COMPONENTS JDI BIOMET 728 120

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R