BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SYSTEM CUP POSITIONER

    MDR report key: 1062819 · Received June 18, 2008

    Report

    Report Number
    1822565-2008-00329
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE LEAD THREAD OF THE CUP POSITIONER EXPERIENCED FRACTURE/ DEFORMATION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: STRIKE MARKS ARE OBSERVED ON THE HANDLE OF THE DEVICE. THE DEVICE SHOWS SOME WEAR FROM USE FROM A POTENTIAL FIELD AGE OF APPROXIMATELY 4 YEARS. THE DEVICE MEETS SPECS AS MEASURED. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPEC. THE REPORTED MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE PREVIOUS TWO YEARS ON A SAME OR SIMILAR DEVICE. AS A RESULT, THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE DOCUMENT PUBLISHED BY THE FDA IN 1997.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE THREADS ON THE CUP POSITIONER ARE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM CUP POSITIONER HIP INSTRUMENT KWB ZIMMER, INC. NA 60141350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK