BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPSILON DURASOL CONSTRAINED INSERT

    MDR report key: 3001404 · Received March 7, 2013

    Report

    Report Number
    1822565-2013-00456
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER OPERATIVE NOTES NOR X-RAYS WERE RETURNED FOR REVIEW; THEREFORE, COMPONENT FIT AND ORIENTATION ARE UNK. IN GENERAL, PT FACTORS THAT MY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. FROM THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S INSERT IS BROKEN AND NEEDS TO BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97968 EPSILON DURASOL CONSTRAINED INSERT KWZ ZIMMER, INC. 61427707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other