BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SYSTEM CUP POSITIONER

    MDR report key: 2042228 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00638
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE LEADING THREADS ON THE INSTRUMENT WERE FOUND TO BE DAMAGED. THE STRIKE SURFACE ON THE INSTRUMENT EXHIBITS A NUMBER OF IMPACTIONS INDICATING THE DEVICE HAS BEEN USED EFFECTIVELY A NUMBER OF TIMES OVER THE POTENTIAL FIELD AGE OF APPROX 3 YEARS. IN GENERAL, THE LEADING THREADS BECOME DAMAGED FROM OFF-AXIS IMPACTIONS SUSTAINED BY THE INSTRUMENT. OFF-AXIS OR NON-AXIAL IMPACTIONS CAN RESULT IN UNINTENDED LOADING CONDITION FOR THE THREADS. THE INCREASED STRESSES MAY EXCEED THE MATERIAL STRENGTH OF THE TREADS AND BECOME DAMAGED AS EXHIBITED IN THE RETURNED DEVICES. WITH THE INFO PROVIDED, EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS OF CUP POSITIONER WERE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM CUP POSITIONER LXH ZIMMER, INC. 60933785

    Patients

    Seq Age Sex Outcome Treatment
    1