BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2013276 · Received March 8, 2011

    Report

    Report Number
    1822565-2011-00536
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    December 17, 2010
    Report Date
    February 7, 2011
    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: RETURNED FOR EVALUATION IS A SMALL SLIVER OF MATERIAL THAT BROKE OFF FROM THE TIBIAL TRAY. THE SURGEON REMOVED THE CHIPPED PIECE AND COMPLETED THE SURGERY. NEITHER THE TIBIAL COMPONENT, THE ARTICULAR SURFACE, NOR THE INSERTER WERE RETURNED FOR EVALUATION. IT IS NOT KNOWN WHETHER CORRECT SURGICAL TECHNIQUE WAS USED TO INSERT THE SURFACE. WITHOUT THE BASEPLATE, SURGICAL NOTES, OR X-RAYS, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. WITHOUT ADD'L INFO, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: DEVICE HISTORY RECORDS INDICATE THE COMPONENT WAS MFG AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING INSERTION OF THE ARTICULAR SURFACE, A FRAGMENT BROKE OFF THE IMPLANTED TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER INC 61615403

    Patients

    Seq Age Sex Outcome Treatment
    1