BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 7235586 · Received February 2, 2018

    Report

    Report Number
    0001825034-2018-00663
    Event Type
    Injury
    Date Received
    February 2, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN THE (B)(6). REPORT SOURCE, LITERATURE - VERSTRAELEN, F.U. ET AL (2017). CLINICAL AND RADIOLOGICAL RESULTS 7 YEARS AFTER COPELAND SHOULDER RESURFACING ARTHROPLASTY IN PATIENTS WITH PRIMARY GLENOHUMERAL OSTEOARTHRITIS: AN INDEPENDENT MULTICENTRE RETROSPECTIVE STUDY. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, 28(1), 15-22. DOI: 10.1007/S00590-017-2023-8. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. 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. 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

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ELEVEN PATIENTS SHOWED SUPERIOR GLENOHUMERAL SUBLUXATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TEN PATIENTS SHOWED SUPERIOR GLENOHUMERAL SUBLUXATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81523 UNKNOWN HUMERAL HEAD PROTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other