BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL KNEE UC PROLONG ARTICULAR SURFACE

    MDR report key: 3980249 · Received July 2, 2014

    Report

    Report Number
    1822565-2014-00811
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 6, 2014
    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

    EVALUATION SUMMARY: THE ARTICULAR SURFACE WAS NOT RETURNED IN THE ORIGINAL PACKAGING. IT CANNOT BE CONFIRMED THAT THE FOREIGN OBJECT WAS PRESENT IN THE ORIGINAL PACKAGING AND NOT INTRODUCED AFTER OPENING. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATION AND ISO STANDARD TO A STERILITY ASSURANCE LEVEL OF (B)(4). THEREFORE, IT IS HIGHLY UNLIKELY THAT USE OF THE SPECIFIED DEVICE WOULD LEAD TO ANY INFECTIONS OR OTHER BIO-INCOMPATIBILITY. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. VISUAL EXAMINATION CONFIRMED A SMALL BLACK FOREIGN OBJECT WITH THE RETURNED ARTICULAR SURFACE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A SMALL SPEC WAS FOUND ON THE ARTICULAR SURFACE WHEN THE PACKAGE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387553 NATURAL KNEE UC PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 62582620

    Patients

    Seq Age Sex Outcome Treatment
    1