BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21384456 · Received February 14, 2025

    Report

    Report Number
    3005180920-2025-00091
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    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 28-01-2024. LOT 2411801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27/09/2024. EXPIRATION DATE: 2029/09/11. 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. CLINICAL EVALUATION: EARLY INFECTION IN RSA, 3 MONTHS AFTER PREVIOUS OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING RSA'S. MOREOVER, HAVING ALREADY UNDERGONE MANY SURGERIES, THE PROBABILITIES COULD HAVE INCREASED. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 28-01-2024 ON REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2415047. LOT 2415047: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/09/2024. EXPIRATION DATE: 2029/09/03. 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 28-01-2024 ON REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE LINER (K170452) LOT. 2011034 LOT 2011034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01/02/2021. EXPIRATION DATE: 2026/01/18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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

    SHOULDER REVISION SURGERY ON THE RIGHT SIDE PERFORMED BY (B)(6) IN (B)(6) ON (B)(6) 2025 FOR INFECTION. NO LOOSENING OF THE COMPONENTS. NO INSTABILITY OF THE JOINT. PRIMARY SURGERY PERFORMED BY DR (B)(6) IN (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 BY DR (B)(6) IN (B)(6) 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 BY DR (B)(6) IN (B)(6) ON (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 BY DR (B)(6) IN (B)(6) ON (B)(6) 2024. EXPLANTATION OF ALL COMPONENTS EXCEPT THE LONG HUMERAL STEM. IMPLANTATION OF A GLENOID CUSTOM IMPLANT ON THE (B)(6) WITH MYSHOULDER PLANNING (M_MOU_RTS_YB_04031948). 4TH REVISION SURGERY PERFORMED BY DR IN (B)(6) ON (B)(6) 2025. EXPLANTATION OF THE GLENOSPHERE, THE LINER AND THE METAPHYSIS. IMPLANTATION OF NEW COMPONENTS (SAME SIZES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638328 SHOULDER SYSTEM SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0173 2411801

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention