BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 18372062 · Received December 21, 2023

    Report

    Report Number
    3005180920-2023-01031
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 5, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 DECEMBER 2023: LOT 2006593: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2020. EXPIRATION DATE: 2025-10-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT. BATCH REVIEW PERFORMED ON 07 DECEMBER 2023 ON REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT. 2218432. LOT 2218432: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 11 MONTHS POST PRIMARY DUE TO SHOULDER LUXATION. LINER AND GLENOSPHERE WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305478 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER REVERSE SYSTEM HIGHCROSS LINER PHX MEDACTA INTERNATIONAL SA 2006593 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention