BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21197089 · Received January 21, 2025

    Report

    Report Number
    3005180920-2024-01179
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    December 27, 2024
    Report Date
    November 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REASON FOR THE FOLLOW UP. ON 24.OCT.2025 THE COMPLAINT (B)(4) WAS NOTIFIED, AND WE DISCOVERED, A FEW DAYS LATER WITH SOME QUESTIONS, THAT THE PATIENT WAS INVOLVED IN THE COMPLAINT (B)(4). THE PATIENT, REVISED IN 2024, HAD THE SECOND STEP REVISION AS PART OF THE ORIGINAL TREATMENT PLAN FOLLOWING THE BONE GRAFT HEALING. THE SURGEON HAD PREVIOUSLY BONE GRAFTED THE GLENOID AND WAS WAITING FOR IT TO HEAL BEFORE HE COULD PERFORM THE REVERSE SHOULDER. THIS IS WHY HE CONVERTED THE PATIENT TO REVERSE. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE MEDACTA HEMIARTHROPLASTY TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED: 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM 2414226 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° 2434141.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 DECEMBER 2024: LOT 173418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2017-07-03. EXPIRATION DATE: 2022-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 30 DECEMBER 2024: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 1905789: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2019-10-31. EXPIRATION DATE: 2024-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD, NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION SURGERY DONE DUE TO BREAKEAGE OF A SCREW AND THE LOOSENING OF THE GLENOSPHERE AND THE BASEPLATE WHICH ARE NOT FROM MEDACTA. THE ONLY PART FROM MEDACTA ARE THE LINER AND THE METAPHYSIS WHICH ARE NOT THE REASON OF THE REVISION. ROOT CAUSE: REVISION SURGERY DONE DUE TO BREAKEAGE OF A SCREW AND THE LOOSENING OF THE GLENOSPHERE AND THE BASEPLATE WHICH ARE NOT FROM MEDACTA. THE ONLY PART FROM MEDACTA ARE THE LINER AND THE METAPHYSIS WHICH ARE NOT THE REASON OF THE REVISION.

    Description of Event or Problem · 0

    REVISION SURGERY 4 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO NOT MEDACTA BASEPLATE LOOSENING, NOT MEDACTA SCREW BREAKAGE AND OSTEOLYSIS FOUND IN THE GLENOID PART. THE SURGEON CONVERTED THE PATIENT TO AN ANATOMIC SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. LINER AND METAPHYSIS ARE THE ONLY MEDACTA PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555712 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0122 173418 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention