BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS NATURAL KNEE ART SURFACE

    MDR report key: 2220290 · Received August 16, 2011

    Report

    Report Number
    1822565-2011-01875
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE CAUSE OF THE UNSUCCESSFUL IMPLANTATION OF THE ARTICULAR SURFACE APPEARS TO BE MISALIGNMENT OF THE DEVICE DURING INITIAL IMPLANTATION; HOWEVER, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. AS RETURNED, THE DEVICE EXHIBIT DEFORMATION DAMAGE, BOTH TO THE ANTERIOR AND POSTERIOR ASPECTS OF THE DEVICE. THE RETAINING TABS ON THE POSTERIOR SIDE OF THE DEVICE APPEAR DEFORMED FROM CONTACT WITH THE RETAINING TABS OF THE TIBIAL TRAY. THE DEFORMATION DAMAGE OF THE MEDIAL TAB IS HEAVIER THAN ON THE LATERAL TAB. THE DEVICE MEASURED WITHIN SPECIFICATIONS AS MEASURED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING; INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED AND PACKAGED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS UNABLE TO PROPERLY INSERT THE ARTICULAR SURFACE. THE SURGERY WAS FINISHED WITH ANOTHER SURFACE OF THE SAME SIZE, HOWEVER, IT WAS CONGRUENT STYLE INSTEAD OF ULTRA-CONGRUENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTIONS NATURAL KNEE ART SURFACE JWH ZIMMER INC 61096398

    Patients

    Seq Age Sex Outcome Treatment
    1