BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5

    MDR report key: 14733623 · Received June 17, 2022

    Report

    Report Number
    3005180920-2022-00465
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728065
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MAY 2022. LOT 2110743: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2021. EXPIRATION DATE: 2026-OCT-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT INVOLVED: BATCH REVIEW PERFORMED ON 20 MAY 2022. REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM (K170452) LOT 2103238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-MAY-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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS AND THE CAUSE IS UNKNOWN. AT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LATERALIZED GLENOSPHERE, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737101 REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 REVERSE SHOULDER SYSTEM GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0207 2110743 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention