BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 50X21X57 HUM HEAD

    MDR report key: 12512011 · Received September 22, 2021

    Report

    Report Number
    0001825034-2021-02660
    Event Type
    Injury
    Date Received
    September 22, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304461093
    PMA / PMN Number
    K193038
    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). EVENT DATE: (B)(6) 2019, EXPLANT DATE: (B)(6) 2019. DEVICE AVAILABLE FOR EVALUATION: (B)(6) 2019. 113614 COMP PRIMARY STEM 14MM MICRO 240540, 118001 VERSA-DIAL/COMP TI STD TAPER 171160, 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 AND SUBSEQUENTLY PATIENT HAD ALLERGIC REACTION TO COBALT CHROME SUFFERING PAIN AND INFLAMMATION. THE HEAD WAS REVISED AFTER APPROXIMATELY TWO YEARS AFTER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414051 VERSA-DIAL 50X21X57 HUM HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 263650 00880304461093

    Patients

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