BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM PRESS-FIT FEMORAL STEM

    MDR report key: 2971881 · Received February 19, 2013

    Report

    Report Number
    1822565-2013-00342
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    October 12, 2007
    Report Date
    January 23, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: OPERATIVE NOTES WERE RETURNED WHICH NOTE THAT A MINI INCISION OF 9.5 CM WAS UTILIZED. THE NOTES ALSO STATE, "THE HEAD WAS DISLOCATED AND BISECTED AT 15MM PER PREOPERATIVE PLANNING, BUT THIS WAS A LONG CUT. ANOTHER 5 MM HAD TO BE TAKEN OFF DOWN TO MORE LIKELY A 15 OR MAYBE A 12 MM CUT EVENTUALLY. THE FEMORAL STEM WAS PROGRESSIVELY BROACHED TO A SIZE 14; HOWEVER, THIS ALSO WAS CUT DOWN AGAIN 5 MM AND THEN RE-REAMED AND BROACHED." CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON SATING THE STEM THE CALCAR WAS FRACTURED. A CABLE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72859 TM PRESS-FIT FEMORAL STEM LPH ZIMMER, INC. 60703032

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention