BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ 30 PROXIMAL

    MDR report key: 2441718 · Received January 3, 2012

    Report

    Report Number
    1651501-2011-00089
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 16, 2011
    Report Date
    January 3, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON WAS PERFORMING A PIP ARTHROPLASTY AND DURING FINAL IMPLANTATION OF A 30P PYROCARBON IMPLANT THE IMPLANT FRACTURED INTO 3 PIECES. THERE WAS AN APPROXIMATE 10 MIN DELAY IN SURGERY. THE DELAY WAS TO REMOVE THE IMPLANT IT WAS FIRMLY FIXED AND NON CEMENTED SO IT WAS DIFFICULT TO REMOVE THE STEM PORTION. THE SURGEON USED A K-WIRE (6.2) AND DRILLED A HOLE IN THE PROXIMAL SHAFT AND USED IT AS AN IMPACTOR TO PUNCH OUT THE IMPLANT. THERE WAS NO INJURY TO THE PT ALL MATERIAL FROM THE FRACTURED IMPLANT WAS RECOVERED AND THE POST OPERATIVE X-RAY WAS NEGATIVE FOR FOREIGN BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ 30 PROXIMAL PIP KYJ ASCENSION ORTHOPEDICS 08-0284

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR