BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21771301 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00285
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-03-2025 LOT 2418600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-11-2024. EXPIRATION DATE: 2029-11-05. 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 IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 24-03-2025 ON REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2419184. LOT 2419184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-10-2024. EXPIRATION DATE: 2029-09-15. 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. BATCH REVIEW PERFORMED ON 24-03-2025 ON REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT. 2311276. LOT 2311276: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-08-2023. EXPIRATION DATE: 2028-07-29. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AND INSTABILITY, PATIENT REPORTED ALSO DISLOCATION. GLENOSPHERE, LINER AND THE METAPHYSIS REVISED. PRIMARY SURGERY PERFORMED BY DR (B)(6) ON THE (B)(6)2021. IMPLANTATION OF REVERSE SHOULDER COMPONENTS + BONE GRAFT AND WITH A CEMENTED STANDARD HUMERAL STEM. MYSHOULDER PLANNING ONLY (M_MIC_RTS_YB_04031948). 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF ALL PRIMARY COMPONENTS. REIMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS + BONE GRAFT AND WITH A LONG HUMERAL STEM. 2ND REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF THE LONG HUMERAL STEM WITH THE METAPHYSIS AND THE LINER + EXPLANTATION OF THE GLENOSPHERE (TO TEST THE STABILITY OF THE BASEPLATE AND THE GRAFT). REIMPLANTATION OF A NEW LONG HUMERAL STEM (CEMENTED) WITH A NEW METAPHYSIS AND LINER +6MM (155 DEGREES) + IMPLANTATION OF A NEW GLENOSPHERE (LATERALIZED). 3RD REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF ALL COMPONENTS EXCEPT THE LONG HUMERAL STEM. IMPLANTATION OF A GLENOID CUSTOM IMPLANT ON THE (B)(6) 2024 WITH MY SHOULDER PLANNING (M_MOU_RTS_YB_04031948). 4TH REVISION SURGERY PERFORMED ON THE (B)(6) 2025. EXPLANTATION OF THE GLENOSPHERE, THE LINER AND THE METAPHYSIS. IMPLANTATION OF NEW COMPONENTS (SAME SIZES). 5TH REVISION SURGERY PERFORMED ON THE (B)(6) 2025. EXPLANTATION OF THE GLENOSPHERE, THE LINER AND THE METAPHYSIS. IMPLANTATION OF NEW COMPONENTS (NEW SAME GLENOSPHERE BUT NEW METAPHYSIS +9MM AND LINER 39/+3MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323325 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø39X27 PHX MEDACTA INTERNATIONAL SA 04.01.0173 2418600 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention