BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD HYBRID GLENOID BASE 4MM

    MDR report key: 12474517 · Received September 15, 2021

    Report

    Report Number
    0001825034-2021-02661
    Event Type
    Injury
    Date Received
    September 15, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304462489
    PMA / PMN Number
    K060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). DATE OF EVENT: (B)(6) 2021. EXPLANT DATE: (B)(6) 2021. CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2021, 113614 COMP PRIMARY STEM 240540, 118001 VERSA-DIAL/COMP TI STD TAPER 523780, UNKNOWN GLENOID HEAD 46MM 828790, 113954 MD HYBRID GLENOID BASE 4MM 268280, PT-113950 GLENOID POST 861990. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL ANATOMIC TOTAL SHOULDER. PATIENT HAD ALLERGIC REACTION TO COBALT CHROME SUFFERING PAIN AND INFLAMMATION. HEAD WAS REVISED ALMOST TWO YEARS LATER. PATIENT CONTINUES TO SUFFER FROM PAIN AND INFLAMMATION. DOCTOR BELIEVES A PATIENT MATCHED IMPLANT TO BE THE BEST FOR THIS PATIENT SO A PMI DEVICE WAS REQUESTED AND SPACER MOLDS WERE INSERTED AS PART OF THIS TWO STAGE REVISION. THE GLENOID COMPONENT WILL BE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370445 MD HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 268280 00880304462489

    Patients

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