BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT

    MDR report key: 1214113 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00733
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AS RETURNED, THE INSTRUMENT IS MISSING A BALL BEARING PROXIMAL TO WHERE THE ARTICULATING SURFACE ATTACHES TO THE INSTRUMENT. IT IS RECOMMENDED THAT THE INSTRUMENT IS NOT DISASSEMBLED BECAUSE THE BEARING WILL FALL OUT; HOWEVER, THERE IS EVIDENCE ON THE HEX-SCREW HEAD THAT THE INSTRUMENT WAS DISASSEMBLED. THE INSTRUMENT MEETS MANUFACTURING SPECIFICATIONS AND HAS A POTENTIAL FIELD LIFE OF 4 YEARS. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALL BEARING FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT KNEE INSTRUMENT LXH ZIMMER, INC. NA 60232243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK