BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM

    MDR report key: 2010536 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00466
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCTS WERE NOT RETURNED FOR REVIEW. X-RAYS, PT'S PAST MEDICAL HISTORY, AND PT'S ACTIVITY LEVEL WERE NOT PROVIDED. SURGICAL NOTE HAS BEEN PROVIDED AND DOES NO INDICATE ANY COMPLICATION. NO CAUSE ANALYSIS CAN BE PERFORMED WITH THE AVAILABLE INFO. EVAL: 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 ADD'L 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 PT WAS REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM LPH ZIMMER, INC. 60631980

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention