BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVERGE ACETABULAR RIM FLARE POROUS SHELL

    MDR report key: 1970912 · Received January 5, 2011

    Report

    Report Number
    1822565-2011-00010
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Report Date
    December 8, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ALL ACETABULAR LINERS INCUR WEAR OVER THEIR LIFE BASED ON THE CONSTRUCTION, PLACEMENT, FIXATION, PT ACTIVITY, PT SIZE, AND A MULTITUDE OF OTHER FACTORS. WHILE ALL EFFORTS ARE MADE TO MINIMIZE THIS WEAR IT CANNOT BE ELIMINATED AND IT IS EXPECTED THAT IN THIS CASE THE PTS ACTIVITIES, BUILD, SURGICAL PLACEMENT AND THE USE OF CONVENTIONAL POLYETHYLENE LED TO THE WEAR DESCRIBED. ASEPTIC LOOSENING OF PROSTHESES THEN CAN HAPPEN FOR A NUMBER OF REASONS, ONE OF WHICH CAN BE THE BODIES REACTION TO POLYETHYLENE WEAR PARTICLES. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH LOOSENING DUE TO WEAR OF THE POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVERGE ACETABULAR RIM FLARE POROUS SHELL HIP PROSTHESIS KWB ZIMMER INC. 1522794

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG# 437638057, LOT# 1487927| CATALOG# 741802150, LOT# 1522982| APR II POROUS DISTAL GRIT BLAST FEMORAL STEM| INTER-OP ACETABULAR DURASUL STANDARD INSERT