BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    MDR report key: 14674610 · Received June 13, 2022

    Report

    Report Number
    3005180920-2022-00445
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 13, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    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 (B)(6) 2022: LOT 2108195: 63 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2022: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452), LOT. 2103683. LOT 2103683: 78 ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2021. EXPIRATION DATE: 2026-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 54 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY 2 MONTHS POST PRIMARY DUE TO SHOULDER INSTABILITY. THE SURGEON REVISED THE LINER AND GLENOSPHERE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181411 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 2108195 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention