BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH MULTI HOLES POROUS

    MDR report key: 1031712 · Received April 18, 2008

    Report

    Report Number
    1822565-2008-00189
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE HISTORY RECORDS INDICATES THAT THE PART WAS MANUFACTURED AND INSPECTED TO SPECIFICATION. THE LOCKING RING MIGHT HAVE BEEN DAMAGED DURING THE IMPACTION OF THE SHELL. NO DEFINITIVE CAUSE ANALYSIS CAN BE DETERMINED WITH CERTAINTY. EVAL: NO PRODUCT WAS RETURNED. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING REVISION SURGERY IN 2008, THE LOCKING RING BENT DURING IMPLANTATION. ANOTHER SHELL WAS NOT AVAILABLE SO THEY CEMENTED A LINER IN PLACE. SURGICAL PROCEDURE WAS EXTENDED AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH MULTI HOLES POROUS HIP PROSTHESIS KWB ZIMMER, INC. NA 60616211

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK