BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN LPS ARTICULAR SURFACE

    MDR report key: 1841544 · Received September 14, 2010

    Report

    Report Number
    1822565-2010-00683
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REVISION SURGERY WAS COMPLETED WITH A 23MM ARTICULAR SURFACE INSTEAD OF A 17MM ARTICULAR SURFACE WHICH IMPLIES THAT THE ORIGINAL ARTICULAR SURFACE WAS FUNCTIONING IN AN UNSTABLE ENVIRONMENT. THIS COULD HAVE ACCOUNTED FOR SOME OF THE WEAR ON THE ARTICULAR SURFACE. HOWEVER, BASED ON AVAILABLE INFORMATION, THE ROOT CAUSE OF THE WEAR NOTED ON THE ARTICULATING SURFACES, WEAR ON THE BACKSIDE OF THE ARTICULAR SURFACE, AND FRACTURE OF THE SPINE POST CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: THE RETURNED ARTICULAR SURFACE COMPONENT SHOWS EVIDENCE OF DELAMINATION AND PITTING DAMAGE ON THE ARTICULATING SURFACES. ALSO, THE SPINE POST HAS FRACTURED OFF AND THE FRACTURED PIECE WAS NOT RETURNED. THE INFERIOR SURFACE SHOWS GROOVES FROM THE TIBIAL TRAY ON THE ANTERIOR PORTION AND WEAR ALONG THE POSTERIOR SURFACE AND DOVETAIL. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK NEXGEN LPS ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention