BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X35 ST

    MDR report key: 20708599 · Received November 18, 2024

    Report

    Report Number
    0001825034-2024-02719
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    October 30, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 FOR LOTS 426670, 483240, AND 483250. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT FOR LOTS 66277264, 65859220, 905710, 384790, 631400, AND 66033987. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED REVISION IS CONFIRMED FROM THE PROVIDED REVISION STICKER SHEET BUT THE REPORTED LOOSENING 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D4/H4: : MULTIPLE LOT #'S WERE PROVIDED FOR THIS SCREW PART #. POSSIBLE LOTS, MANUFACTURING DATES, EXPIRATION DATES, AND UDI #'S ARE AS FOLLOWS: POSSIBLE LOTS: 483240, 483250, 905710. POSSIBLE MANUFACTURING DATES: 483240: OCT 8, 2022. 483250: OCT 8, 2022. 905710: MAR 28, 2022. POSSIBLE EXPIRATION DATES: 483240: OCT 8, 2032. 483250: OCT 8, 2032. 905710: MAR 28, 2032. POSSIBLE UDIS: 483240: (B)(4). 483250: (B)(4). 905710:(B)(4). D10: COMPR VRS GLEN PPS MIN TPR ADR CAT#110027734 LOT#66277264. COMP RVS CNTRL 6.5X35MM ST/RST CAT#115397 LOT#65859220. COMP RVS CNTRL 6.5X40MM ST/RST CAT#115398 LOT#426670. COMP LK SCR 3.5HEX 4.75X45 ST CAT#180556 LOT#384790. COMP LK SCR 3.5HEX 4.75X40 ST CAT#180555 LOT#631400. COMP LK SCR 3.5HEX 4.75X30 ST CAT#180553 LOT#66033987. 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 13 MONTHS POST IMPLANTATION DUE TO GLENOID LOOSENING AND PAIN IN THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION PROCEDURE DUE TO GLENOID LOOSENING AND PAIN IN THE SHOULDER. A CUSTOM GLENOID IS CURRENTLY BEING MANUFACTURED AND THE REVISION PROCEDURE IS PLANNED TO OCCUR APPROXIMATELY 13 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590676 COMP LK SCR 3.5HEX 4.75X35 ST PROSTHESIS, SCREW PHX ZIMMER BIOMET, INC. NI N/A - SEE ADD'L INFO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| H| R SEE H11