BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL PLATE

    MDR report key: 3162167 · Received June 6, 2013

    Report

    Report Number
    1822565-2013-00936
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNKNOWN HOW MANY TIMES THE PACKAGE WAS IN TRANSIT OR WHAT CONDITIONS IT WAS SUBJECTED TO. THE DAMAGE CAN BE ATTRIBUTED TO WEAR AND TEAR THAT ACCRUED DURING THE FIELD LIFE. IT IS LIKELY THAT THE DEVICE EXCEEDED ITS USEFUL LIFE DUE TO WEAR OBTAINED DURING TRANSIT. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION: A NEXGEN STEMMED TIBIA COMPONENT WITH NO PACKAGING WAS RETURNED WITH THE COMPLAINT FOR REVIEW. 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 BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INNER PLASTIC WAS CRACKED AND DAMAGED. ANOTHER IMPLANT WAS OPENED AND USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250728 NEXGEN STEMMED TIBIAL PLATE JWH ZIMMER, INC. 62143599

    Patients

    Seq Age Sex Outcome Treatment
    1