BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM

    MDR report key: 18055001 · Received November 2, 2023

    Report

    Report Number
    3005180920-2023-00844
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    October 3, 2023
    Report Date
    November 2, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    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 10 OCTOBER 2023: LOT 2212977: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 10 OCTOBER 2023: LOT 2247046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2023. EXPIRATION DATE: 2028-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 2 OTHER SIMILAR REPORTED EVENTS IN THE PERIOD OF REVIEW, ONE OF THEM IS ON THE SAME IMPLANT THAT WAS NOT REVISED IN A PRECEDENT SURGERY ON THE SAME PATIENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT HAD A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928745 REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 2212977 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention