BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17296866 · Received July 11, 2023

    Report

    Report Number
    3005180920-2023-00496
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 11, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-JUN-2023. LOT 2115611: (B)(4) MANUFACTURED AND RELEASED ON 01-FEB-2022. EXPIRATION DATE: 2027-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 14-JUN-2023: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT. 189936B LOT 189936B: (B)(4) RELEASED ON 31-JAN-2022. EXPIRATION DATE: 2027-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 5 MONTHS AFTER THE PRIMARY SURGERY, 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
    1586681 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM HUMERAL REVERSE HC LINER Ø39/+6MM PHX MEDACTA INTERNATIONAL SA 2115611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention