BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    MDR report key: 15860123 · Received November 24, 2022

    Report

    Report Number
    3005180920-2022-00896
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2022. LOT 2203310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-APR-04. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING PAIN AND X-RAYS SHOWED THAT GLENOSPHERE BASEPLATE SCREWS WERE BROKEN AND POSSIBLE GLENOID BONE LOSS AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM A REVERSE SHOULDER TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO THE HUMERAL HEAD DIS-ASSOCIATING FROM THE DOUBLE ECCENTER. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE SURGEON CONVERTED THE PATIENT BACK TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896676 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM REVERSE SHOULDER SYSTEM LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 2203310 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention