BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18613586 · Received January 31, 2024

    Report

    Report Number
    3005180920-2024-00013
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 9, 2024
    Report Date
    January 31, 2024
    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 11 JANUARY 2024. LOT 2218468: 75 ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL REVISED IMPLANT: BATCH REVIEW PERFORMED ON (B)(6) 2024 ON REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2247045, LOT 2247045: 60 ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2023. EXPIRATION DATE: 2028-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 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 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LATERALIZED GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246743 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM SHOULDER SYSTEM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 2218468 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention