BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM

    MDR report key: 10800513 · Received November 6, 2020

    Report

    Report Number
    3005180920-2020-00777
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    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 12 OCTOBER 2020: LOT 1908970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2019. EXPIRATION DATE: 2024-10-19. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 12 OCTOBER 2020: REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 (K1704529 LOT. 179112. LOT 179112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2018. EXPIRATION DATE: 2023-03-14. 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 REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HUMERAL REVERSE HC LINER Ø36/+3MM WITH A HUMERAL REVERSE HC LINER Ø36/+6MM 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON DID NOT FEEL HE NEEDED TO REPLACE THE GLENOSPHERE. GLENOSPHERE WAS INTACT AND SECURE. HIS PLAN WAS TO BUILD UP ON THE HUMERAL SIDE WITH TRIALING OTHER POLYS AND THEN ALSO UTILIZING THE MORE CONSTRAINING 155 OPTION TO GET THE JOINT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267344 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0120 1908970 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention