BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM

    MDR report key: 2113459 · Received May 31, 2011

    Report

    Report Number
    1822565-2011-01266
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    January 2, 2007
    Report Date
    May 2, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ONE OR A COMBINATION OF THE FOLLOWING FACTORS MIGHT HAVE CAUSED THE FEMUR FRACTURE: SELECTION OF IMPROPER SIZE FEMORAL PROSTHESIS. IMPROPER PRE-OPERATIVE PLANNING LEADING TO SELECTION OF IMPROPER FEMORAL PROSTHESIS. REMOVAL OF THE IMPROPER PROSTHESIS CAN CAUSE HIGH STRESS AND CONSEQUENT FRACTURE. IMPROPER SURGICAL TECHNIQUE. THIS IS NOT AN EXHAUSTIVE LIST. HOWEVER A DEFINITIVE CAUSE CANNOT BE DETERMINED. EVAL: 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 DURING SURGERY THE FEMUR WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM LPH ZIMMER INC 79403900

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other