BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 11544545 · Received March 22, 2021

    Report

    Report Number
    0001825034-2021-00776
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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). PROCODE: PHX.. CONCOMITANT MEDICAL PRODUCTS: 405800 COMP. REV SHLDR 9 IN STEINMANN 694350; 405883 COMP RVS 3.2MM DRL 103580; 405889 COMP RVS 2.7MM DIA DRL 939740; 115394 COMP RVS CNTRL 6.5X20MM ST/RST 279190; 115395 COMP RVS CNTRL 6.5X25MM ST/RST 877350; 180551 COMP LK SCR 3.5HEX 4.75X20 ST 698730; 180560 COMP NLK SCR 3.5HEX 4.75X30 ST 874220; 180551 COMP LK SCR 3.5HEX 4.75X20 ST 131590; 115310 COMP RVRS SHLDR GLNSP STD 36MM 785350; 113634 COMP PRIMARY STEM 14MM MINI 232400; 110031419 HMRL BEARING 36MM +3 PRLNG 64746324; 110031399 HMRL TRAY STD STD 64855954. 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 THE PATIENT UNDERWENT A RIGHT SHOULDER PROCEDURE ON AN UNKNOWN DATE. THE PATIENT WAS REVISED DUE TO DISASSOCIATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438894 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 785350 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R