BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 2963227 · Received December 20, 2012

    Report

    Report Number
    1822565-2012-02569
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND (B)(4) STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF (B)(4). THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. THE MEASURED DIMENSION OF THE RETURNED ARTICULAR SURFACE WERE WITHIN SPECIFICATION. THE DEVICE EXHIBITED PITTING AND WEAR ON THE CONDYLE CONTACT AREAS AND GOUGES ON THE BOTTOM SIDE. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S KNEE DEVELOPED SWELLING WITH FLUID. THE PT UNDERWENT REVISION DUE TO INFECTION AND IRRIGATION AND DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE MBH ZIMMER, INC. 61574743

    Patients

    Seq Age Sex Outcome Treatment
    1 05/09/1 Required Intervention