BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 19860520 · Received July 30, 2024

    Report

    Report Number
    3005180920-2024-00597
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    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 19 JULY 2024: LOT 2305362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-SEP-2023. EXPIRATION DATE: 2028-SEP-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 19 JULY 2024 REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2103689: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-MAY-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN, DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON ATTEMPTED A CLOSED REDUCTION BUT WAS UNSUCCESSFUL, SO HE PERFORMED AN OPEN REDUCTION INSTEAD. NO IMPLANTS WERE REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240794 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 2305362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention