BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM

    MDR report key: 15072646 · Received July 21, 2022

    Report

    Report Number
    3005180920-2022-00552
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706322
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 JULY 2022: LOT 2108196: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-09-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 07-JUL-2022: REVERSE SHOULDER SYSTEM 04.01.0225 LONG HUMERAL DIAPHYSIS - L200 - 7 (K192967) LOT. 1900937. LOT 1900937: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JULY-2019. EXPIRATION DATE: 2024-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SURGERY OF MEDACTA PRODUCTS ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE HUMERAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PREVIOUS REVISION SURGERY OF COMPETITOR'S PRODUCTS: REVERSE 6+ YEARS POST PRIMARY THAT WAS MISSING A LARGE PORTION OF THE PROXIMAL HUMERUS. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE COMPETITOR GLENOSPHERE AND STEM LOOSENING. THE SURGEON REMOVED THE REVERSE LINER, METAPHYSIS AND STEM AND IMPLANTED AN ANATOMIC METAPHYSIS, DOUBLE ECCENTER AND HUMERAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719743 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM HUMERAL REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0125 2108196 07630040706322

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention