BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM PROVISIONAL FEMORAL BODY REVISION

    MDR report key: 1070976 · Received July 3, 2008

    Report

    Report Number
    1822565-2008-00388
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PROBABLE CAUSE FOR THE INSTRUMENT FRACTURE IS EXCESSIVE FORCE APPLIED WITH A SLAP HAMMER TO DISENGAGE THE INSTRUMENT FROM THE PROVISIONAL STEM. AS RETURNED, THE PREVISIONAL CONE BODY HAS FRACTURED INTO TWO PIECES. THE FRACTURE OCCURRED IN A CIRCUMFERENTIALLY AT APPROXIMATELY THE DISTAL END OF THE NUT. IT APPEARS THAT MOST OF THE DEVICE WAS RETURNED WITH THE COMPLAINT FOR REVIEW WITH ONE SMALL CHIPPED SECTION NOT BEING RETURNED. THE DEVICE SHOWS SOME DEFORMATION MARKS ON THE NECK OF THE DEVICE. ADDITIONALLY, THE HEX FEATURE OF THE NUT SHOWS SOME DEFORMATION DAMAGE. THE DEVICE WAS MANUFACTURED IN JANUARY 2003 AND HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 5 YEARS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE INTACT AND CONFORMING, INDICATING THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PRODUCT FRACTURED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM PROVISIONAL FEMORAL BODY REVISION HIP INSTRUMENT KWB ZIMMER, INC. NA 60003805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK