BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECIMED OFFSET ACETABULAR REA

    MDR report key: 4323636 · Received December 11, 2014

    Report

    Report Number
    0001825034-2014-09089
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    July 2, 2014
    Report Date
    December 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE COMPONENT WAS UNDERSIZED IN SEVERAL LOCATIONS INCLUDING THE KNURLED SURFACE. DESIGN SPECIFICATIONS HAVE BEEN REVISED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLACK HANDLE OF THE ACETABULAR REAMER WOULD NOT FULLY ENGAGE ON THE METALWORK. IT WAS 1"-2" OUT OF POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805329 PRECIMED OFFSET ACETABULAR REA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MDM BIOMET ORTHOPEDICS N/A 2482636

    Patients

    Seq Age Sex Outcome Treatment
    1