BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    MDR report key: 16495662 · Received March 7, 2023

    Report

    Report Number
    3005180920-2023-00126
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. REVISION 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO JOINT LUXATION. THE INDEX SURGERY WAS DONE USING DONOR FROZEN BONE FOR AN EXTENSIVE STRUCTURAL GRAFT OF THE PATIENT HUMERUS. IT IS OF COURSE AN EXTREMELY DIFFICULT OPERATION AND RECUPERATING STABILITY OF THE SHOULDER JOINT IS UNDOUBTEDLY VERY CHALLENGING. THE CAUSES OF THIS ADVERSE EVENT ARE NOT TO BE ATTRIBUTED TO A DEFECTIVE DEVICE. BATCH REVIEW PERFORMED ON 07-MAR-2023. LOT 2210460: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2022. EXPIRATION DATE: 2027-06-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT 2003815A: 17 ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2021. EXPIRATION DATE: 2026-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED BECAUSE OF JOINT LUXATION. THE SURGEON REVISED SUCCESSFULLY METAPHYSIS, LINER AND DIAPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706218 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 2210460 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention