BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 3223794 · Received July 10, 2013

    Report

    Report Number
    1822565-2013-01086
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IDENTIFYING INFORMATION HAS NOT BEEN PROVIDED, SO COMPATIBILITY CONFIRMATION AND MANUFACTURING DOCUMENTATION REVIEWS COULD NOT OCCUR. NEITHER X-RAYS NOR OPERATE NOTES HAVE BEEN RETURNED. NO PATHOLOGY OR OTHER LAB REPORTS HAVE BEEN SUBMITTED OUTLINING THE PATIENT'S ION LEVELS. IN GENERAL, PATIENT FACTORS THAT MAY 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 UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE ON THE AVAILABLE INFORMATION, 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 PATIENT HAS HIGH ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316019 UNKNOWN ZIMMER HIP HIP PROSTHESIS KWA ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other