BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL BASEPLATE

    MDR report key: 3110967 · Received May 9, 2013

    Report

    Report Number
    2648920-2013-00110
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THIS MDR WAS ORIGINALLY SUBMITTED AS 1822565-2013-00066. THE NEW INFORMATION PROVIDED GIVES NO DEFINITIVE INDICATIONS OF A ROOT CAUSE. ARTICULAR SURFACE AND TIBIAL PLATE WERE RETURNED. EVALUATION: THE MEASURED DIMENSIONS OF BOTH DEVICES WERE WITHIN SPECIFICATION AS RETURNED. BOTH SIDES OF THE ARTICULAR SURFACE ARE PITTED AND WORN. BOTH SIDES OF THE TIBIAL PLATE ARE SCUFFED. MANUFACTURING DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICES WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT FELL 6 MONTHS AGO AND EXPERIENCED LEFT KNEE PAIN. THE PATIENT WAS THEN REVISED DUE TO PAIN, LOOSENING, OSTEOLYSIS, AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202546 NEXGEN STEMMED TIBIAL BASEPLATE JWH ZIMMER 60433783

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention LPS ARTICULAR SURFACE,| CATALOG #00599604014, LOT #60223652