BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS EPOCH FULLCOAT FEMORAL HIP STEM

    MDR report key: 2141027 · Received June 21, 2011

    Report

    Report Number
    1822565-2011-01464
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    November 8, 2010
    Report Date
    May 23, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES FROM WHEN THE DEVICE WAS IMPLANTED WERE REVIEWED AND DID NOT NOTE ANY COMPLICATIONS. SURGICAL NOTES FROM THE REVISION WERE ALSO REVIEWED NOTING THAT THE STEM WAS EASILY REMOVED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE MANUFACTURING RECORDS OF THE STEM WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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, (B)(4). CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS EPOCH FULLCOAT FEMORAL HIP STEM LPH ZIMMER INC 60573546

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention