BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM BEADED MIDCOAT COLLARED

    MDR report key: 1211755 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00722
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 1, 2007
    Report Date
    September 25, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT LOOSENING OF THE PROSTHESIS LED TO PAIN AND REVISION FOR A PATIENT 5 YEARS POST-OP. SPECIFIC DETAILS ABOUT LOOSENING WERE NOT GIVEN. THE SHELL OR STEM COULD HAVE BEEN LOOSE INDEPENDENTLY OR BOTH COULD HAVE BEEN LOOSE. LOOSENING COULD HAVE OCCURRED FROM TRAUMA (FALLING IMPACT), OSTEOLYSIS, OR INADEQUATE STEM/SHELL FIXATION. RADIOGRAPHS WERE NOT PROVIDED TO ACCESS STEM/SHELL BONE FIXATION OR CAUSES OF LOOSENING. THEREFORE, THE EXACT CAUSE OF ALLEGED FAILURE COULD NOT BE DETERMINED. METHOD/RESULTS: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED BY PATIENT'S ATTORNEY THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY IN 2002. POST-OP, PATIENT EXPERIENCED PAIN AND WAS REVISED IN 2007 FOR LOOSENING OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM BEADED MIDCOAT COLLARED HIP PROSTHESIS KWY ZIMMER, INC. NA 77356500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R