BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM

    MDR report key: 17316013 · Received July 13, 2023

    Report

    Report Number
    3005180920-2023-00497
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    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 15-JUN-2023. LOT: 2240223: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0279 SENSITIN LAT. GLENOSPHERE 39XØ24.5 (K203755) LOT: 1012763: (B)4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2021. EXPIRATION DATE: 2026-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 WEEK AFTER 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, GLENOSPHERE, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281953 REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0124 2240223 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention