BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MIS HIP INSTRUMENTATION LATERAL ALIGNMENT FRAME

    MDR report key: 1053464 · Received May 28, 2008

    Report

    Report Number
    1822565-2008-00275
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SCREW MIGHT HAVE BEEN FRACTURED DUE TO THE HIGH IMPACT LOAD. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: AS RETURNED, THE A-FRAME IS MISSING THE SCREW ATTACHMENT. IT IS REPORTED THAT THE SCREW FRACTURED DURING IMPACTION AND WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS MANUFACTURED IN FEB 2006 AND COULD HAVE A POTENTIAL FIELD AGE OF APPROX 2 YEARS. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE A-FRAME FRACTURED WHILE HITTING THE CUP IMPACTOR FOR A THA. THE A-FRAME AND BROKEN SCREW WERE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MIS HIP INSTRUMENTATION LATERAL ALIGNMENT FRAME HIP INSTRUMENT LXH ZIMMER, INC. NA 60438241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK