BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 2960309 · Received February 8, 2013

    Report

    Report Number
    1822565-2013-00268
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES WERE PROVIDED AND REVIEWED. THE SURGEON NOTED THAT "WITH THIS PT'S WEIGHT AND THE WAY THAT SHE IS USING HER KNEE IT IS CAUSING THE POLYETHYLENE LOCKING MECHANISM FLANGES TO FAIL." IT WAS NOTED THAT A GENDER SPECIFIC FEMALE NATURAL KNEE SIZE 2 FEMORAL COMPONENT WAS USED WITH THE DEVICE, WHICH IS A SIZE 00/0. THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF X-RAYS AND/OR FURTHER INFORMATION. EVALUATION: DEVICE HISTORY RECORDS INDICATES ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE DEVICE WAS RECEIVED AND EVALUATED BOTH VISUALLY AND DIMENSIONALLY. DEFORMATIONS AND GOUGES WERE NOTED ON THE INFERIOR SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS REVISED DUE TO PAIN CAUSED BY A DISLOCATED ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54256 NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 61012282

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention