BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-41 STD +3 HMRL BRG

    MDR report key: 9977141 · Received April 20, 2020

    Report

    Report Number
    0001825034-2020-01660
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    February 19, 2020
    Report Date
    June 24, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K113121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL EXAMINATION OF THE PROVIDED PICTURE FOR IDENTIFICATION OF THE BROKEN COMPREHENSIVE REVERSE TRAY. WHILE THE TRAY DOES APPEAR TO BE WORN, THIS CANNOT BE CONFIRMED. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF PREVIOUS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. REPORTED EVENT WAS CONSIDERED CONFIRMED AS MEDICAL RECORDS RECEIVED NOTED WORN POLY AND FRACTURED HUMERAL TRAY DURING REVISION PROCEDURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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

    IT WAS FURTHER REPORTED THAT THE PATIENT'S INITIAL SURGERY OCCURRED APPROXIMATELY FOUR (4) YEARS AGO.

    Description of Event or Problem · 0

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

    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: CATALOG #: 113636, COMP PRIMARY STEM 16MM MINI, LOT # 491360. CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 083410. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01684, 0001825034-2020-01685. UNKNOWN IF THE PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUSTAINED A MASSIVE BONE FRACTURE, PAIN AND INSTABILITY AND UNDERWENT INITIAL RIGHT REVERSE TOTAL SHOULDER ON APPROXIMATELY FIVE (5) YEARS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF A REVERSE RIGHT SHOULDER ON ABOUT TWO (2) MONTHS AGO, DUE TO FAILURE OF THE DEVICE WHEN THE PATIENT WAS SIMPLY REMOVING A LANYARD FROM HIS NECK. DURING THIS REVISION PROCEDURE IT WAS NOTED THE TRAY HAD FRACTURED AND BEARING WAS NOTED TO HAVE WEAR. SURGEON WAS UNABLE TO REMOVE THE FRACTURED BASEPLATE AND ELECTED TO REMOVE THE WELL-FIXED STEM. NO COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440066 E1 44-41 STD +3 HMRL BRG PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 855930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R