BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES

    MDR report key: 1211753 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00724
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS IN-VIVO APPROXIMATELY 1 MONTH, AND REVISION SURGERY WAS PERFORMED WITH A MULTI-HOLE TM CUP FIXATED WITH SCREWS, A SIZE 7.5 ML TAPER, A 10 DEGREE ELEVATED RIM POLY LINERS, A 0+ OFFSET FEMORAL HEAD. THE ALLEGED COMPLAINT OF MULTIPLE DISLOCATIONS, SHELL MIGRATION, AND SHELL LOOSENING MAY HAVE BEEN DUE TO ONE OR A COMBINATION OF THE FOLLOWING MECHANISMS. IT IS POSSIBLE THAT THE SHELL WAS NOT FULLY SEATED IN THE PRIMARY SURGERY. THIS MAY HAVE BEEN DUE TO INSUFFICIENT REAMING OF THE ACETABULAR SOCKET, OR INSTABILITY OF THE IMPLANT. THIS MAY HAVE THEN RESULTED IN INSUFFICIENT FIXATION AND A LACK OF INITIAL BONY-IN-GROWTH, WHICH MAY HAVE CAUSED THE SHELL TO MIGRATE FROM ITS ORIGINAL POSITION. ALTERNATIVELY, THE SHELL MAY NOT HAVE BEEN PLACED IN THE CORRECT ANATOMICAL POSITION, AS PER THE SURGICAL TECHNIQUE. THIS MAY HAVE CAUSED THE SHELL TO NOT FULLY SEAT, AND MAY HAVE LED TO DISLOCATION. HOWEVER, NO DEFINITE CAUSE ANALYSIS CAN NOT BE COMPLETED WITH CERTAINTY. 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 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 DEVICE WAS IMPLANTED IN 2008 AND EXPLANTED ON THE FOLLOWING MONTH, DUE TO THE PATIENT'S HIP DISLOCATING TWICE - ONCE POSTERIORLY AND ONCE SUPERIORLY. ON X-RAYS, IT APPEARED THAT THE CUP HAD MOVED AND WAS MORE VERTICAL THAN WHEN INITIALLY IMPLANTED. DR. NASSERI REMOVED THE FEMORAL COMPONENT SO THAT HE COULD VISUALIZE AND POSSIBLY REPOSITION THE CUP. WHEN TRYING TO REMOVE THE POLY LINER FROM THE CUP, THE CUP DISLODGED AND WAS REMOVED. THE ACETABULUM WAS REAMED TO A 56 AND 56 TM MULTI-HOLE CUP WAS IMPLANTED ALONG WITH 3 TRILOGY SCREWS. THE FEMUR WAS BROACHED UP TO A 7.5 FOR AND ML APER STEM. AN ACTUAL 32 MM 10DEG POLY LINER WAS INSERTED. A +0 32MM HEAD WAS APPLIED TO A 7.5 ML TAPER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES HIP PROSTHESIS KWB ZIMMER, INC. NA 60796435

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R