BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM

    MDR report key: 16467482 · Received March 2, 2023

    Report

    Report Number
    3005180920-2023-00111
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 2, 2023
    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 · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2115606: 56 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2023 REVERSE SHOULDER SYSTEM 04.01.0210 LAT. GLENOSPHERE 36XØ27 (K193175) LOT 2008830A: 62 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AT ABOUT 6 MONTHS AFTER PRIMARY DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS AND THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825620 REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0120 2115606 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention