BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP LK SCR 3.5HEX 4.75X25 ST

    MDR report key: 12786912 · Received November 10, 2021

    Report

    Report Number
    0001825034-2021-03096
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 20, 2021
    Report Date
    February 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677159
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT CODE: PHX. CONCOMITANT PRODUCTS: 110031399 HMRL TRAY STD 65222061; 115316 COMP RVRS SHLDR GLNSP 920350; 010000589 COMP RVRS 25MM BSPLT 705700 ; 115394 COMP RVS CNTRL 6.5X20MM 088810; 110031424 HMRL BEARING 36 MM STD 65007502; 113628 COMP PRIMARY STEM 8MM 64877542; 180551 COMP LK SCR 3.5HEX 4.75X20 ST 564830; 180551 COMP LK SCR 3.5HEX 4.75X20 ST 754150; 180550 COMP LK SCR 3.5HEX 4.75X15 ST 910510. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    IT WAS REPORTED THAT DURING THE COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY, THE 25 MM SCREW DID NOT INSERT CORRECTLY AND BECAME STUCK. THE SURGEON TRIED TO USE INNOMED SCREW REMOVAL AND ATTEMPTED PLIERS AND VICE GRIPS AND WAS ABLE TO REMOVE THE SCREW. A BURR WAS USED TO SMOOTH THE TIP AND LEFT THE REST INSIDE THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682883 COMP LK SCR 3.5HEX 4.75X25 ST INSTRUMENT, EXTREMITIES PHX ZIMMER BIOMET, INC. N/A 695870 00880304677159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown