BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HUMERAL TRAY

    MDR report key: 7742532 · Received August 2, 2018

    Report

    Report Number
    0001825034-2018-05387
    Event Type
    Death
    Date Received
    August 2, 2018
    Date of Event
    April 4, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, SRS DISTAL HUMERAL STEM, UNKNOWN SRS PROXIMAL BODY, UNKNOWN GLENOID, UNKNOWN HUMERAL BEARING. UNKNOWN GLENOID BASE PLATE. DAVE R SHUKLA, JULIA LEE, DEVIN MANGOLD, ROBERT H COFIELD, JOAQUIN SANCHEZ-SOTELO, & JOHN W SPERLING,(2018). REVERSE SHOULDER ARTHROPLASTY WITH PROXIMAL HUMERAL REPLACEMENT FOR THE MANAGEMENT OF MASSIVE PROXIMAL HUMERAL BONE LOSS. JOURNAL OF SHOULDER AND ELBOW ARTHROPLASTY, VOLUME 2: PG. 1¿6. DOI: 10.1177/2471549218779845, JOURNALS.SAGEPUB.COM/HOME/SEA. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05661, 0001825034 - 2018 - 05386, 0001825034 - 2018 - 05392 , 0001825034 - 2018 - 05393, 0001825034 - 2018 - 05395.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ROOT CAUSE IS RELATED TO PATIENT CONDITION. PER THE AUTHOR, "NONE OF THE COMPLICATIONS OR FAILURES WERE DUE TO PROBLEMS INHERENT WITH THE IMPLANTS. THEY WERE DUE TO PATIENT CO-MORBIDITIES AND EFFECTS OF HAVING MULTIPLE PRIOR PROCEDURES." 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 THE JOURNAL ARTICLE THAT ONE PATIENT EXPIRED DUE TO UNKNOWN REASONS WITHIN TWO YEAR FOLLOW-UP. THE SPECIFIC CAUSE OF DEATH IS NOT LISTED, HOWEVER, THERE IS NO INDICATION IT IS PRODUCT OR PROCEDURE RELATED WITHIN THE ARTICLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE THAT ONE PATIENT EXPIRED DUE TO UNKNOWN REASONS WITHIN TWO YEAR FOLLOW-UP. THE SPECIFIC CAUSE OF DEATH IS NOT LISTED, HOWEVER, THERE IS NO INDICATION IT IS PRODUCT OR PROCEDURE RELATED WITHIN THE ARTICLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583883 UNKNOWN HUMERAL TRAY PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death