BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 7776685 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04723
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    August 31, 2016
    Report Date
    August 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP MDR IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.THE CORRECTIONS DOES NOT CHANGE ANY PREVIOUSLY REPORTED INVESTIGATION RESULTS. 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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113628, 456550, COMP PRIMARY STEM 8MM MINI; 115310, 574560, COMP RVRS SHLDR GLNSP STD 36MM; 180551, 337990, COMP LK SCR 3.5HEX 4.75X20 ST; 180553, 408800, COMP LK SCR 3.5HEX 4.75X30 ST; 180550, 312830, COMP LK SCR 3.5HEX 4.75X15 ST; 115370, 577900, COMP RVS TRAY CO 44MM; EP-115393, 618320, E1 44-36 STD HMRL BRNG; 115380, 475540, COMP RVS CNTRL SCR 6.5X20MM ST; 115382, 310480, COMP RVS CNTRL SCR 6.5X30MM ST. THE COMPLAINT CANNOT BE CONFIRMED AS THE MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO RELATED DEVIATIONS OR ANOMALIES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04713; 0001825034 - 2018 - 04718; 0001825034 - 2018 - 04722.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS WITHIN ONE MONTH POST PRIMARY SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619759 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 629450

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R