BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2042300 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00589
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2010
    Report Date
    February 18, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PT LABEL FROM 00-5960-014-51 WAS PACKAGED THE SAME DAY BY THE SAME OPERATOR AS THE COMPLAINT IMPLANT (00-5960-016-52); 25 PT LABELS WERE PRINTED FOR 00-5960-014-51. IF ONE WAS MIXED WITH THE 0-5960-016-52 PRODUCT, THEM THE ONE LABEL NOTED AS BEING DESTROYED PER STERILE PACKAGING CHECK SHEET WAS EITHER NOT DESTROYED OR NOT TOTALLY DESTROYED. NO STOCK WAS AVAILABLE AT THE TIME THE COMPLAINT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATION OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A 00-5960-016-52 WAS OPENED AND IMPLANT WAS CONFIRMED AS THE RIGHT IMPLANT. DURING SURGERY, THE NURSE QUESTIONED THE SALES REP AND SURGEON BECAUSE THE PT LABEL STATED A 00-5960-014-51. THE SURGEON AND SALES REP CONFIRMED THAT THE IMPLANT AND BOX WERE THE SAME AND CONTINUED WITH SURGERY. THE PACKAGING AND LABEL WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61359981

    Patients

    Seq Age Sex Outcome Treatment
    1