BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 7901827 · Received September 21, 2018

    Report

    Report Number
    MW5080059
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    September 12, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BIOMET
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. THE PT HAD NO ACUTE EVENT, NO TRAUMA, NO SYMPTOMS UNTIL THIS (B)(6) 2018. X-RAY PERFORMED SUGGESTED SOMETHING BROKE IN THE HIP. PT WAS TAKEN TO SURGERY AND THE LEFT HIP ARTHROPLASTY HAD BEEN NOTED TO HAVE FAILED. "EITHER THE PLASTIC UNSTRAPPED OR THE METAL FAILED ALLOWING THE PLASTIC TO BREAK FREE." THE BALL STARTED RUBBING AGAINST THE SOFT TISSUE AND THERE WAS BLACK METAL IN THE TISSUE FROM THE FAILURE. THE PT HAD TO HAVE A NEW HIP REPLACEMENT IN APPROX 6 YEARS. COMPONENTS PLACED IN 2012: 52 MM LIMITED HOLE RING LOC ACETABULAR SHELL SIZE 23, +3 HIGH WALL 36 MM INNER DIAMETER E1 RINGLOC ACETABULAR LINER, 36 MM BIOLOX DELTA, OPTION CERAMIC HEAD -6 NECK LENGTH BIOLOX TAPER ADAPTER. PT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738402 BIOMET HIP REPLACEMENT JDI BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R