BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM

    MDR report key: 10157888 · Received June 16, 2020

    Report

    Report Number
    3005180920-2020-00333
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 17, 2020
    Report Date
    June 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16-JUN-2020: LOT 1910875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 18-FEB-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39X27 LOT. 1909882 (K170452). BATCH REVIEW PERFORMED ON 16-JUN-2020: LOT 1909882: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2020. EXPIRATION DATE: 16-MAR-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVERSE SHOULDER DISLOCATED 2 DAYS AFTER SURGERY, DUE TO PISTONING OF ABOUT 1CM. NEW COMPONENTS: GLENOSPHERE 39MM LATERALIZED AND +6MM LINER 39MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621621 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 1910875 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention