BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 7323442 · Received March 8, 2018

    Report

    Report Number
    0001825034-2018-01751
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    July 27, 2017
    Report Date
    March 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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. VERSTRAELEN, F. U., HORTA, L. A., SCHOTANUS, M. G., KORT, N. P., SAMIJO, S. K., AND JANSEN, E. J. (2017 ). CLINICAL AND RADIOLOGICAL RESULTS 7 YEARS AFTER COPELAND SHOULDER. DOI:DOI 10.1007/S00590-017-2023-8.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT GLENOID EROSION WAS OBSERVED IN 13 OUT OF 15 SHOULDER PATIENTS. ONE PATIENT SHOWED SEVERE GLENOID EROSION AND SUBLUXATION AFTER 7.5 YEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168254 UNKNOWN HUMERAL HEAD SHOULDER PROSTHESIS KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R