BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5

    MDR report key: 11331837 · Received February 16, 2021

    Report

    Report Number
    3005180920-2021-00120
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706575
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JANUARY 2021: LOT 189745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 25 JANUARY 2021: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452)LOT. 173458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUN-2017. EXPIRATION DATE: 2022-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 4 MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE - Ø39X24.5 WITH A LATERALIZED GLENOSPHERE 39XØ24.5, AND REVISED THE HUMERAL REVERSE HC LINER Ø39/+6MM WITH A HUMERAL REVERSE HC LINER Ø39/+6MM 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229991 REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5 SHOULDER IMPLANT GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0170 189745 07630040706575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention