BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

    MDR report key: 18422519 · Received December 29, 2023

    Report

    Report Number
    1644408-2023-01917
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    December 2, 2023
    Report Date
    December 29, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    PHX
    UDI-DI
    00888912024761
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO PREVIOUS REPORT NUMBER 1644408-2022-01501; 40508-36-101, S803 - DISLOCATION, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236220 GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ENCORE MEDICAL L.P 869C4050 00888912024761

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other| R 506-02-124 LOT: 823C1938| 509-03-436 LOT: 958W1104