BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM STEM IMPACTOR LONG NOSE

    MDR report key: 1163387 · Received September 10, 2008

    Report

    Report Number
    1822565-2008-00592
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE TIP OF DEVICE IS DEFORMED. THE DEFORMATION IS PROBABLY DUE TO REPEATED USE OVER TIME. AS RETURNED, THE INSERTER SHOWS SIGNIFICANT SIGNS OF WEAR. THE TIP HAS DEFORMED, OVER TIME, AND NOW MEASURES ABOVE THE DIMENSIONAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE INSERTING THE STEM, THE TIP OF THE INSERTER GOT STUCK IN THE STEM AND WAS VERY DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM STEM IMPACTOR LONG NOSE HIP INSTRUMENT HWA ZIMMER, INC. NA 60161430

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK