BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30

    MDR report key: 17368998 · Received July 21, 2023

    Report

    Report Number
    3005180920-2023-00535
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706483
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2103988: 240 ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2021. EXPIRATION DATE: 2026-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 217 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. ADDITIONAL DEVICE INVOLVED. BATCH REVIEWS PERFORMED ON 20-JUL-2023: REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2118705: 89 ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2022. EXPIRATION DATE: 2027-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 87 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT 2113523: 70 ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2022. EXPIRATION DATE: 2027-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 61 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER ON (B)(6) 2023: REVISION 1 YEAR AND 1 MONTH AFTER THE PRIMARY RSA, DUE TO A LOOSE GLENOSPHERE AND BASEPLATE. AS IT IS VISIBLE IN THE RADIOGRAPHIC IMAGE, THE MOST SUPERIOR SCREW IS BROKEN. FOR UNKNOWN REASONS THE BASEPLATE WAS NOT ABLE TO INTEGRATE AND IT MAY BE POSSIBLE THAT THERE WAS NOT PRIMARY STABILITY. THEREFORE, IN THESE CONDITIONS THE SCREW COULD NOT INDEFINITELY SUPPORT THE IMPLANTS AND IT BROKE. IT MAY BE POSSIBLE THAT DUE TO THE LOOSENING AN IMPINGMENT BETWEEN THE HUMERUS IMPLANT AND THE GLENOSPHERE MIGHT HAVE HAPPENED.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE BASEPLATE, WHICH HAD ALSO NOT INTEGRATED WITH THE BONE. UPON OPENING THE PATIENT, IT WAS ALSO NOTED THAT ONE OF THE TWO L30 SCREW HAD BROKEN (IT IS UNKNOWN WHICH ONE BROKE). THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922164 REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30 GLENOID POLYAXIAL SCREW PHX MEDACTA INTERNATIONAL SA 04.01.0161 2103988 07630040706483

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention