BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER

    MDR report key: 1129747 · Received August 18, 2008

    Report

    Report Number
    1822565-2008-00524
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, A PORTION OF THE RIM OF THE PROVISIONAL HEAD IS FRACTURED AND MISSING. DAMAGE IS PRESENT INSIDE THE TAPER AND AT THE BOTTOM OF THE TAPER OPPOSITE THE FRACTURED PORTION OF THE RIM. THIS MAY INDICATE THAT AN INSTRUMENT OF SOME SORT WAS LEVERED AGAINST THE BOTTOM OF THE TAPER AND THE RIM, POSSIBLY CAUSING THE RIM FRACTURE. DAMAGE IS ALSO PRESENT ON THE OUTSIDE DIAMETER OF THE HEAD. OTHER POSSIBLE CAUSES OF RIM FRACTURE COULD BE RELATED TO (BUT NOT LIMITED TO) ONE OR MORE OF THE FOLLOWING: DROPPING THE DEVICE; DEGRADATION DUE TO CLEANING/STERILIZATION; IMPACTING THE PROVISIONAL HEAD. HOWEVER, THE EXACT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. AS RETURNED, A PORTION OF THE RIM OF THE PROVISIONAL IS FRACTURED (INTO AN UNK NUMBER OF PIECES) AND IS MISSING. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NOT INDICATION THAT DESIGN OR MANUFACTURE CONTRIBUTED TO THIS OUTCOME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE CRACKED DURING SURGERY, AND PIECES HAD TO BE RETRIEVED FROM THE WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER HIP INSTRUMENT LXH ZIMMER, INC. NA 53776700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK