BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ACETABULAR SYSTEM LINER PROVISIONAL

    MDR report key: 1934484 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01163
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THIS EVENT MAY BE A RESULT OF (BUT NOT LIMITED TO): EXCESSIVE TIGHTENING OF THE POLAR SCREW DURING ASSEMBLY. MATERIAL BECOMING BRITTLE DUE TO CLEANING/AUTOCLAVE PROCESS. DEVICE FATIGUE DUE TO USAGE OVER TIME. ACCIDENTAL DROPPING OF THE PROVISIONAL. ATTEMPTS TO REMOVE THE PROVISIONAL WITH THE SCREW INSTALLED. IMPACTION DURING ASSEMBLY. IN THIS CASE, THE SURGERY DETAILS, CLEANING/AUTOCLAVE PROCESS, AND DEVICE USAGE HISTORY ARE UNKNOWN; THEREFORE, THE EXACT CAUSE CANNOT BE DETERMINED. THE DEVICE WAS RETURNED FOR ANALYSIS. AS RETURNED, IT WAS CONFIRMED THAT MATERIAL HAD FRACTURED OFF FROM AROUND THE POLAR HOLE. THE PIECES THAT FRACTURED OFF WERE NOT RETURNED. THIS PRODUCT HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 4 YEARS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING TO MANUFACTURING, INSPECTION, AND PACKAGING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ACETABULAR SYSTEM LINER PROVISIONAL HIP INSTRUMENT JDI ZIMMER, INC. 60577646

    Patients

    Seq Age Sex Outcome Treatment
    1