BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X30MM ST/RST

    MDR report key: 20611826 · Received November 5, 2024

    Report

    Report Number
    0001825034-2024-02593
    Event Type
    Injury
    Date Received
    November 5, 2024
    Report Date
    April 1, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677081
    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 LK SCR 3.5HEX 4.75X20 ST, CAT# 180551, LOT# 401340; COMP NLK SCR 3.5HEX 4.75X30 ST, CAT# 180560, LOT# 585150; COMP NLK SCR 3.5HEX 4.75X35 ST, CAT# 180561, LOT# 232710; 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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11 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. 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
    72410 COMP RVS CNTRL 6.5X30MM ST/RST PROSTHESIS, SCREW PHX ZIMMER BIOMET, INC. NI 391730 00880304677081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11