BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 19575477 · Received June 20, 2024

    Report

    Report Number
    3005180920-2024-00434
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 24, 2024
    Report Date
    June 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    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 MAY 2024: LOT 2347102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APRIL-2024. EXPIRATION DATE: 2029-03-27. 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 DEVICE INVOLVED BATCH REVIEW PERFORMED ON 28 MAY 2024 REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM (K170452) LOT 2337209: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 2028-11-22. 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. REVERSE SHOULDER SYSTEM 04.01.0216 LONG HUMERAL DIAPHYSIS - L160 - 9 (K192967) LOT 2302357: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2023. EXPIRATION DATE: 2028-05-29. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: SECOND REVISION FEW DAYS AFTER THE FIRST REVISION DUE TO LINER-GLENOSPHERE DISLOCATION AND LOOSENING OF THE DIAPHYSIS. FROM THE RADIOGRAPHIC IMAGE THE STEM MAY HAVE BEEN UNDERSIZED WHILE THE DISLOCATION MAY HAVE HAPPENED DUE TO INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. IN FACT THE SURGEON IN THE REVISION CEMENTED THE STEM AND APPLIED MORE LATERALIZATION. THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON THE (B)(6) 2021. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PROPIONI-BACTERIUM). ALL COMPONENTS WERE SUCCESSFULLY REVISED. REIMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS, BONE GRAFT AND LONG HUMERAL STEM. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LINER-GLENOSPHERE DISLOCATION AND LOOSENING OF THE DIAPHYSIS. THE SURGEON EXPLANTED THE LONG HUMERAL STEM, THE METAPHYSIS, THE LINER AND 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) AND A LATERALIZED GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511147 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 2347102 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention