BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 384253 · Received February 11, 2002

    Report

    Report Number
    MW4003224
    Event Type
    Malfunction
    Date Received
    February 11, 2002
    Date of Event
    January 1, 1999
    Report Date
    February 11, 2002
    Manufacturer
    BIOMET INC
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT RECEIVED A HIP IMPLANT IN 1999. THEY DID NOT RECALL THE EXACT DATE OF THE SURGERY. THE COMPLAINANT SAID IT NEVER HEALED PROPERLY. COMPLAINANT HAS CONSTANT PAIN, THERE IS A CLICKING SOUND IN THE HIP AND A GRINDING FEELING. COMPLAINANT OBTAINED THEIR MEDICAL RECORDS FROM THE HOSP WHERE THE IMPLANT WAS DONE AND PROVIDED INFO REGARDING THE IMPLANT SIZE, PRODUCT NO, ETC. COMPLAINANT HAD PREVIOUSLY DETERMINED THAT THE CERAMIC HEAD HIP JOINT IS UNDER RECALL BY THE MFR. THE PHYSICIAN WHO IMPLANTED THE DEVICE HAS BEEN DIFFICULT TO DEAL WITH AND DOES NOT RETURN THEIR CALLS. THE COMPLAINANT LAST SAW THE DR ABOUT 2 1/2 WEEKS AGO. HE X-RAYED THE HIP AND SAID IT WAS OK. COMPLAINANT INFORMED HIM OF THE RECALL BUT HE DID NOT DISCUSS IT WITH THEM. THE COMPLAINANT IS IN A LOT OF PAIN AND BELIEVES THE IMPLANT SHOULD BE REPLACED. FAILURE TO HEAL AND CONSTANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET NO 163130 MODULAR CERAMIC HEAD, 28 MM HEAD DIAMETER, MINUS 5 LZO BIOMET INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *