BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    MDR report key: 17377164 · Received July 24, 2023

    Report

    Report Number
    3005180920-2023-00583
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 24, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2241367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 2027-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED, BATCH REVIEW PERFORMED ON (B)(6) 2023: REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 (04.01.0172) LOT. 2205800 LOT 2205800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2022. EXPIRATION DATE: 2027-06-01. 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.

    Description of Event or Problem · 0

    AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804125 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM SHOULDER REVERS HC LINER PHX MEDACTA INTERNATIONAL SA 2241367 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Required Intervention