BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALLIANCE REVISION HIP SYSTEM

    MDR report key: 6937667 · Received October 10, 2017

    Report

    Report Number
    0001825034-2017-08406
    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. (B)(4).

    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) YEAR OLD FEMALE THAT WAS FOLLOWED FOR 5 YEARS THAT HAD A DISLOCATION AT 5 DAYS POST-OP AND AN ADDITIONAL DISLOCATIONS AT (UNKNOWN TIME FRAME) TREATED BOTH TIMES WITH A CLOSED REDUCTION ON UNKNOWN DATES. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT'S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715114 UNKNOWN ALLIANCE REVISION HIP SYSTEM PROSTHESIS - HIP KWA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention