BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM TRILOGY IT ALLOFIT IT ACETABULAR SYSTEMS DOME IMPACTOR

    MDR report key: 1634328 · Received March 11, 2010

    Report

    Report Number
    1822565-2010-00152
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: IT IS UNKNOWN WHETHER THE DOME IMPACTOR WAS ASSEMBLED TO THE UNIVERSAL HANDLE AND IMPACTED PROPERLY PER INSTRUCTIONS IN THE SURGICAL TECHNIQUE. IMPROPER ASSEMBLY AND USE COULD HAVE LEAD TO THE REPORTED FRACTURE BUT THE ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY AT THIS TIME. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AS THE SURGEON WAS IMPACTING A CONTINUUM LINER, THE YELLOW DOME IMPACTOR FRACTURED INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TRILOGY IT ALLOFIT IT ACETABULAR SYSTEMS DOME IMPACTOR HIP INSTRUMENT HWA ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK