BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5

    MDR report key: 11207691 · Received January 21, 2021

    Report

    Report Number
    3005180920-2021-00064
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D SHOULDER PROJECT MANAGER: THE GLENOSPHERE SHOWS CIRCULAR MARKINGS ON THE CONVEX BACK SURFACE DUE TO CONTACT WITH ONE GLENOID POLYAXIAL SCREW. THE GLENOSPHERE SCREW HAS CIRCULAR DAMAGES ON THE HEAD AND THE FIRST PORTION OF THE ROD DUE TO FRICTION WITH THE GLENOSPHERE AFTER ITS MOBILIZATION. THE REVERSE METAPHYSIS HAS MINOR BONE RESIDUALS ON THE COATED AREA.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JANUARY 2021: LOT 179110: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2018. EXPIRATION DATE: 2023-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: REVISION OF PRIMARY RSA 1.5 YEARS AFTER INDEX SURGERY FOR GLENOSPHERE/BASEPLATE DISSOCIATION. FROM ONE OF THE XRAYS WE CAN SEE THAT THE GLENOSPHERE DID NOT REACH FULL SEATING ON THE TAPER SPIGOT OF THE BASEPLATE. IN ONE OF THE INTRAOPERATIVE PICTURES, WE CAN SEE THAT THE BASEPLATE FIXATION SCREWS LOOK SLIGHTLY PROTRUDING FROM THE BASEPLATE PLANE. THE BACK OF THE REMOVED GLENOSPHERE SHOWS SIGNS COMPATIBLE WITH RUBBING AGAINST A PROTRUDING SCREW. IN OUR OPINION, THE BASEPLATE FIXATION SCREWS WERE NOT FULLY SEATED AND THEREFORE THE GLENOSPHERE COULD NOT ACHIEVE PROPER FIXATION ON THE CONICAL CONNECTION. WE DO NOT KNOW FOR WHICH REASON THE SCREWS COULD NOT BE FULLY INSERTED. PRELIMINARY INVESTIGATION PERFORMED BY R&D SHOULDER MANAGER: THE PROVIDED X-RAYS CONFIRM BACKING OF THE GLENOSPHERE SCREW, ROTATION OF THE GLENOSPHERE AND SUBSEQUENT SCAPULAR NOTCHING. BLACK-COLOURED SOFT TISSUES CONFIRM MOBILIZATION OF THE IMPLANT AND FRICTION BETWEEN METAL COMPONENTS. INSPECTION OF THE EXPLANTS IS REQUIRED TO DETERMINE THE ROOT CAUSE. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 JANUARY 2021 REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT. 1810997. LOT 1810997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 2024-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING REGULAR FOLLOWING UP, THE SURGEON CONFIRMED THE GLENOSPHERE ROTATION AND SCAPLAR NOTCHING THROUGH THE XRAY. REVISION SURGERY PERFORMED 1 YEAR AND 7 MONTHS AFTER PRIMARY. GLENOSPHERE, LINER AND REVERSE METAPHYSIS HAVE BEEN REPLACED. THE SURGEON ONCE REMOVED THE LOCKING SCREWS AND REINSERTED THEM AND RETIGHTENED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106881 REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0169 179110 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention