BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 50X21X57 HUM HEAD

    MDR report key: 8603152 · Received May 13, 2019

    Report

    Report Number
    0001825034-2019-02065
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 18, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI# (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). FOREIGN-(B)(6). CONCOMITANT MEDICAL PRODUCTS: PART 113954; LOT 410050; MD HYBRID GLENOID BASE 4MM; PART 118001; LOT 652590; VERSA-DIAL/COMP TI STD TAPER; PART PT-113950; LOT 760210; PT HYBRID GLEN POST REGENEREX; PART 113611; LOT 170140; COMP PRIMARY STEM 11MM MICRO. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. 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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO COMPREHENSIVE ANATOMIC TO REVERSE SHOULDER ON (B)(6) 2019. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396772 VERSA-DIAL 50X21X57 HUM HEAD EXTREMITIES, IMPLANT HSD ZIMMER BIOMET, INC. N/A 990650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R