BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS MINI TOTAL KNEE PROCEDURE ADJUSTABLE INTRAMEDULLARY FEMO

    MDR report key: 1021949 · Received March 28, 2008

    Report

    Report Number
    1822565-2008-00142
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY- IT IS NOT KNOWN WHETHER THE IM CANAL WAS PREPARED PER THE RECOMMENDED TECHNIQUE BEFORE INSERTING THE GUIDE WHICH CAN RESULT IN THE BINDING OF THE GUIDE ROD. ALSO, THE CURVED FEMUR ANATOMY COULD BE A CONTRIBUTING FACTOR TO THE BINDING. THE CAUSE OF THE DEVICE STICKING IN THE FEMUR COULD NOT BE DEFINITIVELY DETERMINED DUE TO INSUFFICIENT INFO. RESULTS AND CONCLUSION- THE DEVICE EXHIBITS HEAVY DEFORMATION DAMAGE AT APPROX THE BASE OF THE CUT GUIDE. ONE OF THE PINS HAS FRACTURED OFF THE CUT GUIDE AND THE OTHER IS BENT. THE PROXIMAL END OF THE IM ROD EXHIBITS SUBSTANTIAL DEFORMATION DAMAGE FROM REPEATED USAGE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NO INDICATION THAT DESIGN OR MFR CONTRIBUTED TO THIS OUTCOME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGICAL PROCEDURE IN 2008, THE SURGEON GOT THE DEVICE STUCK IN THE FEMUR AND HAD TO HAMMER IT OUT. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS MINI TOTAL KNEE PROCEDURE ADJUSTABLE INTRAMEDULLARY FEMO KNEE INSTRUMENT LXH ZIMMER, INC. NA 60158513

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK