BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECIMED OFFSET ACETABULAR REA

    MDR report key: 4669778 · Received April 8, 2015

    Report

    Report Number
    0001825034-2015-01404
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    March 11, 2015
    Report Date
    June 2, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-01404 & 01405).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO INSTRUMENT WEAR AND MISUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REAMERS WERE FOUND TO HAVE LOOSE HANDLES. THE REPORTED ISSUE WITH THE INSTRUMENTS DID NOT TAKE PLACE DURING A PROCEDURE AND NONE OF THE PRODUCTS WERE FIRST TIME USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232862 PRECIMED OFFSET ACETABULAR REA INSTURMENT LXH BIOMET ORTHOPEDICS N/A 7066930001-32

    Patients

    Seq Age Sex Outcome Treatment
    1