BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 9915308 · Received April 2, 2020

    Report

    Report Number
    0001825034-2020-01285
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    March 10, 2020
    Report Date
    June 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED CONFIRMED AS THE X-RAYS SHOWED THE GLENOSPHERE DISSOCIATING FROM THE BASEPLATE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 931820, CATALOG #: 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT # 305350, CATALOG #: 110031424, CR VIVACIT-E 36MM BRNG STD, LOT # 64510452, CATALOG #: 110031399, MINI TRAY STD COCR +0 OFFSET, LOT # 64666142, CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 062930, CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 630330, CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 453810, CATALOG #: 115397, COMP RVS CNTRL 6.5X35MM ST/RST, LOT # 911560. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. 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 SHOULDER ARTHROPLASTY. SUBSEQUENTLY PATIENT WAS REVISED TWO WEEKS LATER AS PATIENT FELT POP IN SHOULDER DOING NORMAL DAILY ACTIVITIES. THE PATIENT'S X-RAY SHOWED THE GLENOSHOHERE HAS DISASSOCIATED FROM BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378132 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 350770 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R