BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN OFFSET STEM EXTENSION

    MDR report key: 3040307 · Received April 3, 2013

    Report

    Report Number
    1822565-2013-00594
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF PRODUCT OR FURTHER INFORMATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE IMPACTING AN OFFSET STEM EXTENSION ONTO LCCK FEMORAL COMPONENT, THERE WAS A GAP BETWEEN THE STEM AND FEMORAL COMPONENT. THE TORQUE SCREW WAS BACKED OUT AND THIS TIME AFTER BACKING OFF TORQUE SCREW, THE STEM FIT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136958 NEXGEN OFFSET STEM EXTENSION NJL ZIMMER, INC. 60922552

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NEXGEN LCCK FEMORAL COMPONENT, CAT# 00599401592,| LOT# 61957933