BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8151417 · Received December 11, 2018

    Report

    Report Number
    0001825034-2018-11047
    Event Type
    Injury
    Date Received
    December 11, 2018
    Report Date
    April 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THE COMPLAINT CANNOT BE CONFIRMED AS NO MEDICAL RECORDS WERE PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITE 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115310 COMP RVRS SHLDR GLNSP STD 36MM 928200, 113652 COMP PRIMARY STEM 12MM STD 903880, 115370 COMP RVS TRAY CO 44MM 672680, XL-115363 ARCOM XL 44-36 STD HMRL BRNG 812120, 180550 COMP LK SCR 3.5HEX 4.75X15 ST 317350, 180551 COMP LK SCR 3.5HEX 4.75X20 ST 445120, 180552 COMP LK SCR 3.5HEX 4.75X25 ST 317450, 115396 COMP RVS CNTRL 6.5X30MM ST/RST 650460. (B)(4). THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11055, 0001825034 - 2018 - 11057, 0001825034 - 2018 - 11058, 0001825034 - 2018 - 11059.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER AND NOW HAS REPORTED UNEXPLAINED PAIN ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993362 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 271880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other