BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR OTJ METAL PROVISIONAL PROXIMAL BODY

    MDR report key: 2278367 · Received September 20, 2011

    Report

    Report Number
    1822565-2011-02112
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED COMPONENT WAS FUNCTIONALLY TESTED AND FUNCTIONED AS INTENDED WHEN USED AS DIRECTED IN SURGICAL TECHNIQUE. BASED OFF THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION: THE PROVISIONAL WAS MEASURED AND FOUND TO BE CONFORMING TO SPECIFICATION WHERE MEASURED. THERE ARE BUFF MARKS AROUND THE NECK AND BODY OF THE PROVISIONAL AS WELL AS IMPRESSION AND BURS AROUND THE BASE OF THE PROVISIONAL. THE IMPRESSION LEFT ON THE PROVISIONAL LOOKS LIKE IMPACT MARKS FROM A KNURLED SURFACE. THERE WAS A BUR ON BOTH SIDES OF THE THRU HOLE IN THE BODY OF THE PROVISIONAL. DEVICE HISTORY RECORDS INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROVISIONAL CONE BODY WOULD NOT DISENGAGE FROM THE HIP STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR OTJ METAL PROVISIONAL PROXIMAL BODY LXH ZIMMER, INC. 61135709

    Patients

    Seq Age Sex Outcome Treatment
    1