BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM

    MDR report key: 16992286 · Received May 24, 2023

    Report

    Report Number
    3005180920-2023-00359
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    April 24, 2023
    Report Date
    May 24, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706339
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 APRIL 2023: LOT 2240224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: THE PATIENT HAD A PRIMARY RSA SURGERY ON (B)(6)2023. AFTER THAT TIME, THE PATIENT HAD 3 REVISIONS DUE TO INSTABILITY AND THEN DISLOCATION OF THE JOINT. THE PATIENT WAS REVISED ON A 4TH TIME STILL DUE TO DISLOCATION. THEREFORE, THE SURGEON CHANGED THE REVERSE IMPLANT INTO A SALVAGE HEMIARTHROPLASTY WITH AN ANATOMICAL METAPHYSIS, DOUBLE ECCENTER, AND HUMERAL HEAD AND EXPLANTING THE BASEPLATE, SCREWS, GLENOSPHERE, REVERSE METAPHYSIS, AND INSERT. THESE EVENTS ARE NORMAL ORIGINATED BY PROGRESSION OF DISEASE TO THE SOFT TISSUES, DEFORMITY OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND; HOWEVER, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON 27 APRIL 2023 ON REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5 (K193175) LOT. 2103993 LOT 2103993: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2021. EXPIRATION DATE: 2026-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6)2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6)2023, THE PATIENT CAME REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, GLENOSPHERE, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6)2023, THE PATIENT CAME IN DUE TO SIGNS OF A DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A SALVAGE HEMIARTHROPLASTY WITH AN ANATOMICAL METAPHYSIS, DOUBLE ECCENTER, AND HUMERAL HEAD AND EXPLANTED THE BASEPLATE, SCREWS, GLENOSPHERE, REVERSE METAPHYSIS, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509559 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM SHOULDER REVERSE HIGH-CROSS LINER PHX MEDACTA INTERNATIONAL SA 04.01.0126 2240224 07630040706339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention