BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM

    MDR report key: 1843554 · Received September 22, 2010

    Report

    Report Number
    1822565-2010-00787
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 29, 2008
    Report Date
    August 26, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE X-RAYS DESCRIBED HAVE NOT BEEN PROVIDED. IN ADDITION, NO FURTHER DETAILS REGARDING THE FRACTURE WERE GIVEN AND NO PARTS WERE RETURNED. IT IS UNKNOWN WHAT COMPONENT FRACTURE AND WHERE THE FRACTURE OCCURRED DUE TO THE LACK OF INFORMATION. AT THIS TIME, NO DEFINITIVE CAUSE ANALYSIS CAN BE COMPLETED WITH CERTAINTY WITHOUT ADDITIONAL INFORMATION. EVALUATION: 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 RE-OPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT WAS REVISED FOR A FRACTURE IN THE HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM HIP PROSTHESIS LPH ZIMMER INC. 60056653

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention