BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-36 STD +3 HMRL BRG

    MDR report key: 9649378 · Received January 30, 2020

    Report

    Report Number
    0001825034-2020-00450
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    May 17, 2019
    Report Date
    June 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K113121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: COMP RVS TRAY CO 44MM CAT: 115370 LOT: 858330, COMP RVRS 25MM BSPLT HA+ADPTR CAT: 010000589 LOT: 370190, COMP RVSR SHLDR GLNSP +3 36MM CAT: 115313 LOT: 792460, COMP RVS CNTRL 6.5X25MM ST/RST CAT: 115395 LOT: 755190, COMP LK SCR 3.5HEX 4.75X15 ST CAT: 180550 LOT: 351810, COMP LK SCR 3.5HEX 4.75X20 ST CAT: 180551 LOT: 071950, COMP PRIMARY STEM 9MM MINI CAT: 113629 LOT: 575960. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED 14 DAYS POST-IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110335 E1 44-36 STD +3 HMRL BRG SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. N/A 512100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10