BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39X27

    MDR report key: 10037574 · Received May 8, 2020

    Report

    Report Number
    3005180920-2020-00277
    Event Type
    Injury
    Date Received
    May 8, 2020
    Date of Event
    April 30, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES WERE RETURNED ON 13-MAY-2020 AND ANALYZED ON 25-MAY-2020. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. GLENOID BASEPLATE: MILD RESORPTION OF HYDROXYAPATITE IS VISIBLE AT THE BONE-IMPLANT INTERFACE; NO BONE RESIDUALS ARE PRESENT; A PORTION OF THE TAPER IS DULL, PRESUMABLY DUE TO RELATIVE MOVEMENT OF THE GLENOSPHERE AFTER THE DISSOCIATION; GLENOSPHERE: THE ARTICULAR SURFACE PRESENTS SOME SCRATCHES, PRESUMABLY OCCURRED AFTER THE DISSOCIATION; MILD DISCOLORATION IS VISIBLE ON A SMALL REGION OF THE TAPER AND OF THE CURVED BACKSURFACE; HUMERAL REVERSE METAPHYSIS: MILD RESORPTION OF HYDROXYAPATITE IS VISIBLE ON THE OUTER SURFACE; GLENOID POLYAXIAL SCREWS: ONE OF THE THREE SCREWS IS BROKEN IN THE TERMINAL PART (CLOSE TO THE TIP).

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07-MAY-2020: LOT 179114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2018. EXPIRATION DATE: 08-MAR-2023. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 07-MAY-2020: REVERSE SHOULDER SYSTEM 04.01.0156 GLENOID BASEPLATE Ø27X35 (K170452) LOT 183534: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-JUL-2018. EXPIRATION DATE:17-AUG-2023. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: MOBILIZATION OF THE GLENOSPHERE IN A COMPLEX REVISION REVERSE SHOULDER ARTHROPLASTY CASE, ONE WEEK AFTER IMPLANTATION OF BONE GRAFT TO REPOSITION THE GLENOID COMPONENT. THIS HAPPENED IMMEDIATELY, SO IT MUST BE PRESUMED THAT THE CONSTRUCT NEVER FOUND SUFFICIENT POSTOPERATIVE STABILITY. WE DO NOT HAVE SIGNIFICANT COMMENTS TO OFFER, BUT WE DO NOT SEE ANY DEFECTIVE DEVICE AS EVIDENTLY RESPONSIBLE FOR THIS DIFFICULT SITUATION.

    Description of Event or Problem · 1

    THE PATIENT CAME AFTER A FRACTURE SEQUELAE OF A FOUR PARTS FRACTURE, ANATOMIC TSA HAS BEEN PERFORMED. AFTER THE SHOULDER ARTHROPLASTY THERE WAS A SECONDARY CUFF FAILURE, A SINGLE-STAGE REVISION TO REVERSE SYSTEM HAS BEEN PERFORMED, POOR BONE INFERIOR, FAILURE OF THE BASEPLATE AND BONE BREAK OUT. A SINGLE-STAGE REVISION SURGERY HAS BEEN PERFORMED USING MY SHOULDER TO A LONG PEG WHICH WENT PERFECTLY ((B)(6) 2019). ONE WEEK AFTER THE REVISION SURGERY, DURING PENDULUM EXERCISES, THE PATIENT FELT A POP IN HIS SHOULDER. AFTER A X-RAYS CONTROL, IT WAS CLEAR THAT THE GLENOSPHERE TWISTED OF ABOUT 180° UPWARDS AND THE CENTRAL SCREW UNSCREWED (4 MONTHS AFTER THE PRIMARY). IN THE X-RAYS THE SCREW APPEARS TO BE IN THE CENTRAL HOLE OF THE BASEPLATE. THE REVISION SURGERY, TO ANATOMIC SYSTEM, HAS BEEN COMPLETED SUCCESSFULLY ON (B)(6) 2020: THE SURGEON REMOVED BASEPLATE, GLENOSPHERE, GLENOID SCREWS, REVERSE LINER AND HUMERAL REVERSE METAPHYSIS AND ASSEMBLED AN ANATOMIC METAPHYSIS, DOUBLE ECCENTER AND HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502699 REVERSE SHOULDER SYSTEM GLENOSPHERE 39X27 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0173 179114 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention