BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 1841919 · Received August 31, 2010

    Report

    Report Number
    2648920-2010-00036
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WITHOUT ADDITIONAL INFORMATION, THE ORIGINS OF THE METAL PIECE AND WHAT MIGHT HAVE CAUSED IT TO APPEAR CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL NOT REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT, DURING THE PROCESS OF IMPLANTING THE TIBIAL PLATE AND THE ARTICULAR SURFACE, A PIECE OF METAL WAS NOTICED WHICH MAY HAVE FRACTURED OFF OF THE TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT PRECOAT KNEE PROSTHESIS JWH ZIMMER 61341515

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR