BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP. REV SHLDR 9 IN STEINMANN

    MDR report key: 16410374 · Received February 21, 2023

    Report

    Report Number
    0001825034-2023-00354
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 23, 2023
    Report Date
    July 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    FZX
    UDI-DI
    00887868504563
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, D2, G3, H1, H2, H3, H5, H6, H10 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 886240. CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 437540. CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 098780. CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 918800. CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 855910. CATALOG #: 115398, COMP RVS CNTRL 6.5X40MM ST/RST, LOT # 655670. CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 656600. CATALOG #: 113611, COMP PRIMARY STEM 11MM MICRO, LOT # 65319533. CATALOG #: 110031424, CR VIVACIT-E 36MM BRNG STD, LOT # 65434165. CATALOG #: 110031399, MINI TRAY STD COCR +0 OFFSET, LOT # 65398274 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS BEEN REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00355, 0001825034-2023-00356, 0001825034-2023-00357, 0001825034-2023-00358, 0001825034-2023-00359, 0001825034-2023-00360, 0001825034-2023-00361, 0001825034-2023-00362, 0001822565-2023-00438, 0001822565-2023-00439. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO AN SUSPECTED NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319681 COMP. REV SHLDR 9 IN STEINMANN EXTREMITY IMPLANTS FZX ZIMMER BIOMET, INC. N/A 130520 00887868504563

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R