BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 50X27X50 HUM HEAD

    MDR report key: 7422230 · Received April 11, 2018

    Report

    Report Number
    0001825034-2018-02490
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 9, 2018
    Report Date
    April 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    PK060716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: 113954, MD HYBRID GLENOID BASE 4MM, 572670; 113651, COMP PRIMARY STEM 11MM STD, 858680; 113057, VERSA-DIAL 50X27X50 HUM HEAD, 092570; PT-113950, PT HYBRID GLEN POST REGENEREX, 090950. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TO A REVERSE SHOULDER DUE TO UNKNOWN REASONS. THE COMPREHENSIVE TOTAL SHOULDER WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264180 VERSA-DIAL 50X27X50 HUM HEAD PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 092570

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R