BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39X27

    MDR report key: 10250223 · Received July 9, 2020

    Report

    Report Number
    3005180920-2020-00401
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 20, 2020
    Report Date
    July 21, 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
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION THE VISUAL INSPECTION WAS PERFORMED ON (B)(6) 2020. THE REVERSE METAPHYSIS SHOWS SIGNS OF BONE GROWTH ON THE OUTER SURFACE, IN PROXIMITY OF THE REGION COATED WITH HA COATED. THE OUTER CHAMFER OF THE PE REVERSE LINER IS DAMAGED. IT IS NOT POSSIBLE TO DETERMINE IF THIS OCCURRED DURING THE REMOVAL OF THE LINER DURING THE REVISION SURGERY OR FOLLOWING REPEATED CONTACT WITH THE BONE OR OTHER IMPLANT COMPONENTS. THE GLENOSPHERE DOES NOT PRESENT MILD SCRATCHES ON THE ARTICULAR SURFACE. THE GLENOSPHERE SCREW HAS CIRCULAR SCRATCHES WHICH ARE LIKELY TO BE RELATED TO FRICTION WITH THE GLENOSPHERE CENTRAL BORE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08-JULY-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 WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 09 JULY 2020: REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE 27X15 (K170452) LOT 1810999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2018. EXPIRATION DATE: 2024-02-18. 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: DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE IN RSA AFTER FEW MONTHS. REPORTEDLY, THE PATIENT WAS UNDERTAKING SERIOUS PHYSICAL EFFORTS, BUT THIS SHOULD NOT BE PER SE A CAUSE FOR DISSOCIATION. IT IS POSSIBLE THAT A DEVIATION FROM THE SPECIFIC SURGICAL TECHNIQUE MAY INFLUENCE THE CORRECT ASSEMBLY OF THE COMPONENTS. THE TECHNICAL ANALYSIS DID NOT REPORT A PRODUCT DEFECT. THE DEFINITIVE CAUSE FOR THIS ADVERSE EVENT CANNOT BE DETERMINED WITH THE INFORMATION AT HAND PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D SHOULDER MANAGER: IN THE PROVIDED X-RAY THE GLENOSPHERE APPEARS TO BE DISSOCIATED FROM THE BASEPLATE AND THE SCREW IS PARTIALLY OUT OF ITS INTENDED POSITION. VISUAL INSPECTION PERFORMED BY MEDACTA R&D SHOULDER MANAGER: THE REVERSE METAPHYSIS SHOWS SIGNS OF BONE GROWTH ON THE OUTER SURFACE, IN PROXIMITY OF THE REGION COATED WITH HA COATED. THE OUTER CHAMFER OF THE PE REVERSE LINER IS DAMAGED. IT IS NOT POSSIBLE TO DETERMINE IF THIS OCCURRED DURING THE REMOVAL OF THE LINER DURING THE REVISION SURGERY OR FOLLOWING REPEATED CONTACT WITH THE BONE OR OTHER IMPLANT COMPONENTS. THE GLENOSPHERE DOES NOT PRESENT MILD SCRATCHES ON THE ARTICULAR SURFACE. THE GLENOSPHERE SCREW HAS CIRCULAR SCRATCHES WHICH ARE LIKELY TO BE RELATED TO FRICTION WITH THE GLENOSPHERE CENTRAL BORE.

    Description of Event or Problem · 1

    THE PATIENT IS A FARMER, HE WAS OPERATED IN (B)(6) 2019. THE PATIENT REPORTED THAT HE HAS HOED THE GROUND IN HIS FIELD, FROM (B)(6) 2020. HE NOW FELT A LOUD NOISE DURING THE NIGHT, IN THE SHOULDER, AND PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE AND UNSCREWING OF THE GLENOSPHERE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714877 REVERSE SHOULDER SYSTEM GLENOSPHERE 39X27 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0173 179114 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention