BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTREMITY

    MDR report key: 7014995 · Received November 9, 2017

    Report

    Report Number
    0001825034-2017-10109
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    November 9, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE: CISNEROS, L. G., ATOUN, E., ABRAHAM, R., TSVIELI, O., BRUGUERA, J., & LEVY, O. (2016). REVISION SHOULDER ARTHROPLASTY: DOES THE STEM REALLY MATTER? JOURNAL OF SHOULDER AND ELBOW SURGERY,25(5), 747-755. DOI:10.1016/J.JSE.2015.10.007. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE CONDITION IS ADDRESSED IN 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. ZIMMER BIOMET COMPLAINT:(B)(4).

    Description of Event or Problem · 1

    J SHOULDER ELBOW SURG (2015) HTTP://DX.DOI.ORG/10.1016/J.JSE.2015.10.007 CISNEROS, L., ET AL INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "REVISION SHOULDER ARTHROPLASTY: DOES THE STEM REALLY MATTER?" A RETROSPECTIVE REVIEW WAS CONDUCTED OF DATA THAT WERE PROSPECTIVELY COLLECTED ON PATIENTS WHO UNDERWENT REVISION SHOULDER ARTHROPLASTY AT OUR INSTITUTE BETWEEN 2005 AND 2012. TWO (2) STEMMED ARTHROPLASTY (STA) REVISIONS FOR GLENOID NOTCHING AND GLENOID LOOSENING WERE IDENTIFIED IN THE ARTICLE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN. ALL OTHER EVENTS WILL BE REPORTED IN INDIVIDUAL RECORDS WHICH WILL BE LINKED TO PARENT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792564 UNKNOWN EXTREMITY PROSTHESIS - SHOULDER HSD ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R