BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5

    MDR report key: 13470948 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00079
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 13, 2022
    Report Date
    February 7, 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 17 JANUARY 2022: LOT 2004027: 17 ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-APR-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 17 JANUARY 2022: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2108189: 90 ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-SEP-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 75 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JANUARY 2022: LOT 2004027: 17 ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-APR-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 17 JANUARY 2022: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2108189: 90 ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-SEP-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 75 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 OF THE INSTABILITY IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487238 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0207 2004027 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention