BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5

    MDR report key: 16476398 · Received March 3, 2023

    Report

    Report Number
    3005180920-2023-00088
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 14, 2023
    Report Date
    March 3, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706575
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE GLENOSPHERE SHOWS MINOR SCRATCHES ON THE ARTICULAR SURFACE, LIKELY DUE TO FRICITON WITH THE HUMERAL REVERSE METAPHYSIS AFTER JOINT DISLOCATION. MOREOVER, THE TAPER IS PARTIALLY DULL. THE GLENOSPHERE SCREW HAS CIRCULAR SCRATCHES ON THE HEAD AND THE SHAFT. THE OUTER RIM OF THE REVERSE LINER IS DAMAGED. THIS, TOO, MAY HAVE OCCURRED AFTER JOINT DISLOCATION, GIVEN THE INFORMATION AT HAND IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE JOINT DISLOCATION, NOR OF THE LOOSENING OF THE GLENOSPHERE SCREW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. REVISION AT ABOUT 7 MONTHS AFTER THE TOTAL REVERSE SHOULDER ARTHROPLASTY DUE TO JOINT LUXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER GLENOSPHERE, SCREW AND LINER. THESE EVENTS ARE NORMAL ORIGINATED BY INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. GIVEN THE PATIENT HUMERUS CONDITION, IT IS PROBABLY DIFFICULT TO STABILIZE THIS JOINT. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2115425: 114 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 92 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER COMPONENTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 2113346: 71 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 68 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE 24,5X15 (K170452) LOT 2116433: 200 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 189 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT HAD A PRIMARY SHOULDER SURGERY AND MEDACTA REVERSE SHOULDER SYSTEM WAS IMPLANTED. PRESENTLY, ON (B)(6) 2023, THE PATIENT WAS REVISED DUE TO JOINT LUXATION. DURING REVISION SURGERY, THE SURGEON NOTICED THAT THE SCREW OF THE GLENOSPHERE WAS LOOSE AND THAT THERE WAS A VERY FEW FIXATION ON THE TAPER. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER GLENOSPHERE, SCREW AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934146 REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5 SHOULDER REVERSE GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0170 2115425 07630040706575

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention