BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X20 ST

    MDR report key: 10165123 · Received June 17, 2020

    Report

    Report Number
    0001825034-2020-02385
    Event Type
    Injury
    Date Received
    June 17, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677142
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, G4, H1, H2, H3, H6, AND H10. REPORTED EVENT WAS CONSIDERED CONFIRMED, AS THE X-RAYS SHOWED A FRACTURE OF THE INFERIOR MOST GLENOID SCREW. AND LIKELY LOOSENING OF THE MIDDLE SCREW. 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.

    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 #: 115396, COMP RVS CNTRL 6.5X30MM ST/RST, LOT # 047100. CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 451680. CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 651170. CATALOG #: 180554, COMP LK SCR 3.5HEX 4.75X35 ST, LOT # 390400. CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 621330. CATALOG #: 115326, COMP RVRS SHLDR GLNSP +6 41MM, LOT # 513060. CATALOG #: XL-115366, ACROM XL 44-41 STD HMRL BRNG, LOT # 812470. CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 547270. CATALOG #: 113636, COMP PRIMARY STEM 16MM MINI, LOT # 004810. CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 870550. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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: 0001825034-2020-02382, 0001825034-2020-02383, 0001825034-2020-02384, 0001825034-2020-02387.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE X-RAY RECEIVED THAT THERE IS A CONFIRMED FRACTURE OF AN INFERIOR SCREW IN THE GLENOID, LOOSENING OF ANOTHER SCREW, AND LUCENCY SURROUNDING THE CENTRAL SCREW. A REVISION IS PLANNED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627100 COMP LK SCR 3.5HEX 4.75X20 ST FASTENER, FIXATION KWS ZIMMER BIOMET, INC. N/A 641470 00880304677142

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE