BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR MICROPLASTY CUP INSERTER

    MDR report key: 1982150 · Received January 18, 2011

    Report

    Report Number
    1982150
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    November 8, 2010
    Report Date
    January 18, 2011
    Manufacturer
    BIOMET
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER THE IMPLANT WAS IN, WHILE LOOKING AT THE INSTRUMENT (ACETABULAR CUP IMPLANT HANDLE) THE CLINICIAN NOTICED THAT THERE WAS A PIECE MISSING. THE SURGEON HAD LEFT THE ROOM. HE WAS CALLED BACK, A C-ARM IMAGE WAS TAKEN AND IT WAS NOTED THAT SOMETHING WAS IN THE ACETABULUR CUP LINER. THE SURGEON RETRIEVED 3 PIECES OF THE IMPACTOR. A C-ARM IMAGE WAS TAKEN WHICH SHOWED NO OTHER PARTS OF THE IMPACTOR. THE PIECES OF THE IMPACTOR WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR MICROPLASTY CUP INSERTER ACETABULAR CUP IMPLANT HANDLE JDI BIOMET * 131480

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR