BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROVISIONAL STEMMED TIBIAL COMPONENT

    MDR report key: 2062897 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00660
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 18, 2010
    Report Date
    January 20, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE EXHIBITS WEAR INDICATIVE OF SIGNIFICANT USE IN THE FIELD. ACCORDING TO THE MANUFACTURING RECORDS, THE DEVICE HAS A POTENTIAL FIELD AGE OF OVER 11 YEARS. BASED ON THE AVAILABLE INFORMATION, IT HAS BEEN DETERMINED THAT THIS INSTRUMENT HAS EXCEEDED ITS USEFUL LIFE. RETURNED ITEM WAS DIMENSIONALLY VERIFIED TO MEET PRINT SPECIFICATION. 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 BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PLASTIC TRIAL BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROVISIONAL STEMMED TIBIAL COMPONENT LXH ZIMMER, INC. 58980200

    Patients

    Seq Age Sex Outcome Treatment
    1