BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL PLATE

    MDR report key: 3820033 · Received May 14, 2014

    Report

    Report Number
    2648920-2014-00121
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    January 6, 2012
    Report Date
    December 2, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION RECEIVED VIA OPERATIVE NOTES. PRIMARY OPERATIVE NOTES REPORT EXCELLENT RANGE OF MOTION AND STABILITY AFTER IMPLANTATION OF THE FINAL COMPONENTS. IT IS UNK IF THE CEMENT WAS ALLOWED TO CURE WITH THE KNEE IN FULL EXTENSION. REVISION OPERATIVE NOTES INDICATE ASPECT LOOSENING. THE TIBIAL COMPONENTS WAS REPORTED TO BE GROSSLY LOOSE AND WAS REMOVED EASILY. THE FEMORAL COMPONENT WAS NOT REPORTED TO BE LOOSE AND THE CONDITION OF THE ARTICULAR SURFACE WAS NOT MENTIONED. ROOT CAUSE REMAINS UNK AT THIS TIME. EVALUATION: DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE INFORMATION SUBMITTED ON THIS REPORT WAS PREVIOUSLY SUBMITTED UNDER MEDWATCH NUMBER 1822565-2013-01889.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288915 NEXGEN STEMMED TIBIAL PLATE JWH ZIMMER 60260518

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention PALACOS R+G BONE CEMENT,| PALACOS R+G BONE CEMENT,| CATALOG# 00111314001, LOT #68164202| CATALOG# 00111314001, LOT #67594195