BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP NLK SCR 3.5HEX 4.75X35 ST

    MDR report key: 20611586 · Received November 5, 2024

    Report

    Report Number
    0001825034-2024-02597
    Event Type
    Injury
    Date Received
    November 5, 2024
    Report Date
    April 1, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677289
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: COMP RVRS 25MM BSPLT HA+ADPTR CAT# 010000589 LOT# 297750; COMP RVS CNTRL 6.5X30MM ST/RST CAT# 115396 LOT# 391730; COMP LK SCR 3.5HEX 4.75X20 ST CAT# 180551 LOT# 401340; COMP NLK SCR 3.5HEX 4.75X30 ST CAT# 180560 LOT# 585150; COMP LK SCR 3.5HEX 4.75X30 NS CAT# 180567 LOT# 429360. G2: UNITED KINGDOM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS NOT CONFIRMED. 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

    IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR A REVISION PROCEDURE APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO THE GLENOID LOOSENING. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72405 COMP NLK SCR 3.5HEX 4.75X35 ST PROSTHESIS, SCREW PHX ZIMMER BIOMET, INC. NI 232710 00880304677289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11.