BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17387717 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00545
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 25, 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 3 JULY 2023: LOT: 183527: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2018. EXPIRATION DATE: 2023-JUN-10. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 3 JULY 2023 REVERSE SHOULDER SYSTEM 04.01.0178 GLENOSPHERE 32XØ24.5 (K170452) LOT: 2117361: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2027-MAR-02. 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 WAS UNKNOWN. ABOUT 5 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
    633265 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 183527 07630040706254

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention