BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM

    MDR report key: 18191336 · Received November 22, 2023

    Report

    Report Number
    3005180920-2023-00949
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    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 21 NOVEMBER 2023 LOT 2248488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 21 NOVEMBER 2023: REVERSE SHOULDER SYSTEM 04.01.0210 LAT. GLENOSPHERE 36XØ27 (K193175) LOT 189940C: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2022. EXPIRATION DATE: 2027-11-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722529 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM SHOULDER REVERSE LINER PHX MEDACTA INTERNATIONAL SA 2248488 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention