BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM CEMENTED COLLARED

    MDR report key: 1241527 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00820
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    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 ALLEGED COMPLAINT REFERS TO A VERSYS FEMORAL COMPONENT LOOSENING FROM THE CEMENT IN THE CANAL. THE STEM WAS NOT RETURNED FOR EVAL. THE INITIAL SURGERY WAS IN 04 WITH A REVISION SURGERY OF 08. THE PT WAS A SMALL, FEMALE, BUT HER ACTIVITY LEVEL WAS NOT STATED. ADDITIONAL SURGERY INFO (INCLUDING CEMENT TYPE, X-RAYS, AND/OR PHOTOGRAPHS) WAS NOT PROVIDED. CAUSE CAN NOT BE DEFINITELY DETERMINED BASED ON THE INFO PROVIDED. 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 SPECS. 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 RE-OPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INITIAL HIP REPLACEMENT TOOK PLACE IN 2004 AND PT WAS REVISED IN 2008, DUE TO FEMORAL COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM CEMENTED COLLARED HIP PROSTHESIS KWY ZIMMER, INC. NA 41646000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R