BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLIANCE REVISION HIP SYSTEM

    MDR report key: 6937661 · Received October 10, 2017

    Report

    Report Number
    0001825034-2017-08404
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WALLNER, O., STARK, A., MUREN, OL, EISLER, T., SKOLDENBERG, O. (2014) UNSTABLE HIP ARTHROPLASTIES. A PROSPECTIVE COHORT STUDY ON SEVENTY DISLOCATING HIPS FOLLOWED UP FOR FOUR YEARS. INTERNATIONAL ORTHOPAEDICS (SICOT), DOI 10.1007/S00264-014-2583-8. RECEIVED: 9 OCTOBER 2014/ACCEPTED: 23 OCTOBER 2014. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. CONDITION IS ADDRESSED IN THE PACKAGE INSERT. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "UNCEMENTED UNSTABLE HIP ARTHROPLASTIES. A PROSPECTIVE COHORT STUDY ON SEVENTY DISLOCATING HIPS FOLLOWED UP FOR FOUR YEARS." THE ARTICLE IDENTIFIED A (B)(6) OLD MALE THAT HAD A DISLOCATION 75 DAYS POST HIP ARTHROPLASTY. FOLLOWING THIS SAME (B)(6) OLD MALE HAD ANOTHER DISLOCATION ON AN UNKNOWN DATE. BOTH DISLOCATIONS WERE TREATED WITH A CLOSED REDUCTION. THIS PATIENT WAS FOLLOWED FOR FIVE (5) YEARS. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT'S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715112 ALLIANCE REVISION HIP SYSTEM PROSTHESIS - HIP KWA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention