BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALLIANCE REVISION HIP

    MDR report key: 7054122 · Received November 22, 2017

    Report

    Report Number
    0001825034-2017-10495
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. LITERATURE: WALLNER, O. "UNSTABLE HIP ARTHROPLASTIES" (2014). INTERNATIONAL ORTHOPAEDICS. DOI 10.1007/200264-014-2583-8.

    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) FEMALE THAT WAS FOLLOWED FOR 6 YEARS THAT HAD A DISLOCATION AT 886 DAYS POST-OP AND AN ADDITIONAL DISLOCATION 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
    832579 UNKNOWN ALLIANCE REVISION HIP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R