BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR PROLONG 36MM BRNG STD

    MDR report key: 12198056 · Received July 20, 2021

    Report

    Report Number
    0001822565-2021-02014
    Event Type
    Injury
    Date Received
    July 20, 2021
    Report Date
    December 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231490
    PMA / PMN Number
    K181611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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 THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: 110031405 HMRL TRAY 64607897. 115310 COMP RVRS SHLDR GLNSP 141400. 118000 TAPER ADAPTOR 559650. 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 - 02150, 0001825034 - 2021 - 02150.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093180 CR PROLONG 36MM BRNG STD PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 64653419 00887868231490

    Patients

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