BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM

    MDR report key: 17773090 · Received September 19, 2023

    Report

    Report Number
    3005180920-2023-00706
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706254
    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 24 AUGUST 2023: LOT 2103686: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-09. 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. BATCH REVIEW PERFORMED ON 23 AUGUST 2023: REVERSE SHOULDER SYSTEM 04.01.0118 HUMERAL REVERSE HC LINER Ø32/+6MM (K170452) LOT 2201876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APRIL-2022. EXPIRATION DATE: 2027-03-20. 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

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER DISLOCATING ANTERIORLY DURING PHYSICAL THERAPY AFTER THE PT PULLED ON THE ARM. THE SURGEON REVISED THE POLY AND METAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891674 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 2201876 07630040706254

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention