BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 42XØ27

    MDR report key: 19151098 · Received April 22, 2024

    Report

    Report Number
    3005180920-2024-00230
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706612
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 MARCH 2024: LOT 2103684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2021. EXPIRATION DATE: 2026-APR-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOVLED: BATCH REVIEW PERFORMED ON 27 MARCH 2024: REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE Ø27X15 (K170452) LOT 2110377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2021. EXPIRATION DATE: 2026-NOV-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: TWO YEARS AFTER THE PRIMARY SURGERY, THE PATIENT UNDERWENT RADIOGRAPHIC ANALYSIS DUE TO PAIN AND ROM DECREASE. FROM THE RADIOGRAPHIC IMAGES IT IS VISIBLE THAT THE GLENOSPHERE ECCENTRICITY IS UPSIDE DOWN. THE GLENOSPHERE DISSOCIATED FROM THE BASEPLATE. NO REVISION SURGERY DATE IS DEFINED YET. SINCE THE GLENOSPHERE GUIDE WAS NOT USED DURING THE PRIMARY SURGERY, IT MAY BE POSSIBLE THAT THE GLENOSPHERE DID NOT REACH ITS FINAL SEATING AND WITH TIME THE IMPLANT DISSOCIATED FROM THE BASEPLATE.

    Description of Event or Problem · 0

    ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, XRAYS SHOWED THAT THE GLENOSPHERE ECCENTRICITY IS UPSIDE DOWN AND THAT THE GLENOSPHERE IS DISSOCIATED FROM THE BASEPLATE. REVISION SURGERY DATE IS NOT DEFINED YET. GLENOSPHERE GUIDE WAS NOT USED DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592570 REVERSE SHOULDER SYSTEM GLENOSPHERE 42XØ27 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 2103684 07630040706612

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other