BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CRUCIATE RETAINING TIBIAL COMPONENT

    MDR report key: 1940551 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01393
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED BECAUSE OF VARIOUS MALALIGNMENT ISSUES. THE DEVICE WAS IMPLANTED IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CRUCIATE RETAINING TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE SCREW SELF-TAPPING: CATALOG # 00625006550,| ARTICULAR SURFACE: CATALOG # 00595204010,| HGP II ACETABULAR COPONENTS BONE SCREW| SELF-TAPPING: CATALOG # 00662406540, LOT # UNK| NEXGEN COMPLETE KNEE SOLUTION CRUCIATE REAIING| LOT # 60200473| (CR) FEMORAL COMPONENT: CATALOG # 00597201602,| NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAIING| LOT # UNK (QTY. 3)| (CR) PROLONG HIGHLY CROSSLINKED POLYTETHYLENE| LOT # 60221693