BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17413520 · Received July 28, 2023

    Report

    Report Number
    3005180920-2023-00585
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    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 2203311: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2022. EXPIRATION DATE: 2027-APR-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL REVISED IMPLANT: BATCH REVIEW PERFORMED ON (B)(6) 2023 ON REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) LOT. 2115425. LOT 2115425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2022. EXPIRATION DATE: 2027-FEB-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER, GLENOSPHERE, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337220 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM SHOULDER REVERSE SYSTEM HIGH-CROSS LINER PHX MEDACTA INTERNATIONAL SA 2203311 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention