BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5

    MDR report key: 15994321 · Received December 16, 2022

    Report

    Report Number
    3005180920-2022-00962
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    December 8, 2022
    Report Date
    December 16, 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 12 DECEMBER 2022: LOT 2004002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2103236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2021. EXPIRATION DATE: 2026-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° LOT. 2003875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE 36XØ24.5MM GLENOSPHERE WITH A 39XØ24.5MM GLENOSPHERE, REVISED THE Ø36/+3MM LINER WITH A Ø39/+0MM AND REVISED THE +0MM/0° METAPHYSIS WITH A +9MM/0° METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439662 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0207 2004002 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention