BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21383094 · Received February 14, 2025

    Report

    Report Number
    3005180920-2025-00069
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-01-2025: LOT 2110370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-11-2021. EXPIRATION DATE: 2026-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION 2 YEARS AND 8 MONTHS AFTER PRIMARY RSA IN AN 83-YEAR-OLD FEMALE PATIENT DUE TO BASEPLATE LOOSENING. FROM THE ONLY RADIOGRAPHIC IMAGE PROVIDED, NO DEFINITIVE INFORMATION CAN BE DEDUCED. IT IS POSSIBLE THAT SUBOPTIMAL BONE QUALITY OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION CONTRIBUTED TO THIS EVENT. HOWEVER, NO FURTHER CONCLUSIONS CAN BE DRAWN BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 8 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE BASEPLATE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE BASEPLATE, SCREWS, GLENOSPHERE, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. 6 SCREWS WERE REPORTED AMONG THE REVISED DEVICES, IT IS NOT KNOWN IF ALL OF THEM WERE USED AND HOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415765 SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25 PHX MEDACTA INTERNATIONAL SA 04.01.0190 2110370

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention