BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

    MDR report key: 14684867 · Received June 14, 2022

    Report

    Report Number
    3005180920-2022-00469
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MAY 2022. LOT 2103929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-MAY-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 20 MAY 2022: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT 2003977: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-MAR-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA CLINICAL AFFAIRS SPECIALIST: SECOND REVISION 6 MONTHS AFTER THE PRIMARY RSA IN A FEMALE PATIENT DUE TO DISLOCATION OF THE JOINT. ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO JOINT DISLOCATION. ACCORDING TO REPORT, ABOUT 20 DAYS AFTER THE FIRST REVISION, THE JOINT DISLOCATED AGAIN DURING PHYSIOTHERAPY: THE GLENOSPHERE, METAPHYSIS AND LINER WERE REVISED. PROBABLY LOW ARTICULAR TENSION AND PROBLEMS WITH SOFT TISSUE MANAGEMENT ARE AT THE ORIGIN OF THIS PROBLEM. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO JOINT DISLOCATION (ALL COMPONENTS REVISED EXCEPT FOR THE BASEPLATE). ABOUT 20 DAYS AFTER THE FIRST REVISION, THE JOINT DISLOCATED AGAIN DURING PHYSIOTHERAPY (METAPHYSIS AND LINER REVISED). DURING THIS REVISION, IT WAS NOTED THAT THE PROSTHESIS WAS NOT REDUCING BECAUSE OF SOFT AND RESIDUAL TISSUES (EG OF TRACHITIS) THAT INTERPOSED IN THE POSTERIOR PART AND KEPT THE JOINT DISLOCATED ANTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249075 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0124 2103929 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention