BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2831713 · Received November 9, 2012

    Report

    Report Number
    1822565-2012-02317
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO BREAKAGE OF THE ARTICULAR SURFACE AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE MBH ZIMMER, INC. 60476927

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention LOT # 07307900| CAT # 00598605701, LOT # 18756900| MANUFACTURED BY ZIMMER (B)(4)| NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT:| NEXGEN LPS FEMORAL COMPONENT: CAT # 00599601602