BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS NK FLEX FEMORAL COMPONENT

    MDR report key: 2930369 · Received January 22, 2013

    Report

    Report Number
    1822565-2013-00139
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    December 18, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 UNDERWENT AN ARTHROSCOPIC PROCEDURE DUE TO PAIN AND EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30219 GENDER SOLUTIONS NK FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61410025

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention GENDER SOLUTIONS NATURAL-KNEE FLEX ROTATING| CATALOG #00543202109, LOT #61076542| PLATFORM ARTICULAR SURFACE| CATALOG #630803101, LOT #61341766| NK II ROTATING PLATFORM TIBIAL BASEPLATE,