BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 9579973 · Received January 13, 2020

    Report

    Report Number
    3005180920-2019-01143
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    January 7, 2020
    Report Date
    January 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JANUARY 2020. LOT 1811894: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2019. EXPIRATION DATE: 2024-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC. LINER Ø36/+6MM (K170452) LOT. 179979. BATCH REVIEW PERFORMED ON 10 JANUARY 2020. LOT 179979: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2018. EXPIRATION DATE: 2023-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER. THE COMPONENTS REMAINED INTACT AND WE CANNOT DETECT ANY HINT OF A DEFECT THAT LED TO THE PROBLEM. THESE EVENTS ARE NORMALLY ORIGINATED BY PROGRESSION OF DISEASE TO THE SOFT TISSUES OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND.

    Description of Event or Problem · 1

    SURGEON REPORTED ABOUT A REVERSE SHOULDER UNSTABLE, WHICH EASILY DISLOCATES (LINER - GLENOSPHERE). GLENOSPHERE, LINER, METAPHYSIS SUCCESSFULLY REVISED, 7 WEEKS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44919 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 REVERSE GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 1811894 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention