BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 16MM MINI

    MDR report key: 9977133 · Received April 20, 2020

    Report

    Report Number
    0001825034-2020-01684
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    February 19, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00880304457546
    PMA / PMN Number
    K060692
    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). UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    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.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: EP-115397, E1 44-41 STD +3 HMRL BRG, LOT # 855930. 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: 0001825034-2020-01660, 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
    440054 COMP PRIMARY STEM 16MM MINI PROSTHESIS SHOULDER HSD ZIMMER BIOMET, INC. N/A 491360 00880304457546

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE