BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM VERSA-DIAL TAPER ADAPTOR

    MDR report key: 12198051 · Received July 20, 2021

    Report

    Report Number
    0001825034-2021-02150
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THE TAPER ADAPTER IS A SUB COMPONENT OF THE BASEPLATE/TAPER AND HAS THUS ALREADY BEEN REPORTED UNDER THAT DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THE TAPER ADAPTOR IS A SUBCOMPONENT OF THE BASEPLATE/TAPER AND HAS THUS ALREADY BEEN REPORTED UNDER THAT DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: PHX. CONCOMITANT PRODUCTS: 110031418 36MM BRNG STD 64653419; 110031405 HMRL TRAY 64607897; 115310 COMP RVRS SHLDR GLNSP 141400; 010000589 BSPLT HA+ADPTR 224960; 405800 REV SHLDR 9IN STEINMANN 270200. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02148, 0001825034 - 2021 - 02149, 0001822565 - 2021 - 02014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH A REVERSE SHOULDER DISLODGED HER GLENOSPHERE APPROXIMATELY FOUR MONTHS LATER AND OPTED TO WAIT SIX MONTHS FOR A REVISION DESPITE SURGEON'S REQUEST TO REVISE SOONER. GLENOSPHERE AT POINT OF DISLOCATION CREATED EXTREME POLY WEAR AND CAUSED SIGNIFICANT WEAR TO THE MINI BASEPLATE AND WARPING OF THE MINI BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093010 25MM VERSA-DIAL TAPER ADAPTOR PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 559650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R