BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5

    MDR report key: 14346257 · Received May 10, 2022

    Report

    Report Number
    3005180920-2022-00353
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 10, 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 13 APRIL 2022. LOT 2008828A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2021. EXPIRATION DATE: 2026-JUL-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 13 APRIL 2022. REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT 2103237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUN-2021. EXPIRATION DATE: 2026-MAY-17. 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 THE CAUSE WAS UNKNOWN. AT 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376094 REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 REVERSE SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0207 2008828A 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention