BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 12367549 · Received August 25, 2021

    Report

    Report Number
    0001825034-2021-02500
    Event Type
    Injury
    Date Received
    August 25, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IT IS ALLEGED THAT THE PATIENT MAY HAVE HAD A FALL, HOWEVER; WITHOUT MEDICAL RECORDS A DEFINITIVE ROOT CAUSE CANNOT 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). PRODUCT CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: 110031424 CR VIVACIT-E 36MM BRNG 64673394. 110031400 MINI TRAY +5MM 64490875. 113615 COMP PRIMARY STEM 347540. 115310 COMP RVRS SHLDR GLNSP 907910. 115394 COMP RVS CNTRL ST/RST 976340. 180550 COMP LK SCR 3.5HEX 4.75X15 ST 098230. 180551 COMP LK SCR 3.5HEX 4.75X20 ST 652690. 180553 COMP LK SCR 3.5HEX 4.75X30 ST 803260. 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 THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS SCHEDULED FOR REVISION SURGERY DUE UNSPECIFIED INJURIES AS A RESULT OF A TRAUMATIC FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264722 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 504600 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10