BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER

    MDR report key: 1214108 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00729
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT WAS ALLEGED THAT THE SURGEON PREPARED THE FEMUR FOR A SIZE 15 MM X 185 MM TAPER ZMR STEM, SEATED THE PROVISIONAL STEM APPROPRIATELY, THEN INSERTED THE IMPLANT STEM WHICH SUBSIDED INTRAOPERATIVELY. A 19 MM X 235 MM ZMR TAPER STEM WAS INSTEAD IMPLANTED SUCCESSFULLY. THE SIZE DISCREPANCY BETWEEN THE PREPARED BONE CAVITY AND STEM MAY BE CAUSED BY A VARIETY OF REASONS INCLUDING SURGICAL PROCEDURE, REAMING ANGLE, INCORRECT PROVISIONAL STEM SIZE, AND/OR PT BONE QUALITY. NO DEVICES OR X-RAYS WERE RETURNED FOR THIS EVAL. THE EXACT CAUSE OF THIS COMPLAINT CAN NOT BE DETERMINED WITH THE CURRENT INFO. EVAL: NO PRODUCT WAS RETURNED. 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 IN 2008, THE SURGEON WAS GOING TO IMPLANT A 15 X 185 AFTER REAMING AND BROACHING APPROXIMATELY THE STEM DID NOT FILL, DO WE HAD TO USE A 19 X 235 STEM IN ORDER TO GET CORRECT FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER HIP PROSTHESIS KWY ZIMMER, INC. NA 60832339

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR