BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP +6 36MM

    MDR report key: 8674646 · Received June 6, 2019

    Report

    Report Number
    0001825034-2019-02413
    Event Type
    Injury
    Date Received
    June 6, 2019
    Report Date
    June 28, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    K120906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 115330, LOT# 612120, COMP RVRS SHDR GLEN BSPLT +HA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THEY REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02372, 0001825034-2019-02372-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO FRACTURE OF THE GLENOID COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469797 COMP RVRS SHLDR GLNSP +6 36MM EXTREMITIES, IMPLANT HSN ZIMMER BIOMET, INC. N/A 474230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other