BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    MDR report key: 15247455 · Received August 18, 2022

    Report

    Report Number
    3005180920-2022-00618
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-JUL-2022 LOT 2100436: 126 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-03-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 112 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18-AUG-2022. REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT. 2103682 LOT 2103682: 78 ITEMS MANUFACTURED AND RELEASED ON 28-APR-2021. EXPIRATION DATE: 2026-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 60 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED THE DAY AFTER THE PRIMARY DUE TO JOINT DISLOCATION. THE LOOSEN JOINT REQUIRED MORE DISTALIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245164 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM HUMERAL REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 2100436 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention