BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21812115 · Received April 10, 2025

    Report

    Report Number
    3005180920-2025-00230
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-MARCH-2025: LOT 189863A: (B)(4) ITEMS RELEASED ON 05-01-2022. EXPIRATION DATE: 2026-12-08. 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. FATHER LOT 189863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-03-2019. EXPIRATION DATE: 2024-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD (3 AS 189863A AND 1 AS 189863B) WITH NO SIMILAR EVENTS REPORTED DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 19-MARCH-2025: REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM (K170452) LOT 2108186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-09-2021. EXPIRATION DATE: 2026-09-03. 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. REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058) LOT 2201532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-06-2022. EXPIRATION DATE: 2027-05-18. 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 BX MEDICAL AFFAIRS DEPARTMENT: REVISION 1 YEAR 11 MONTHS AFTER PRIMARY RSA DUE TO INSTABILITY. ACCORDING TO REPORT THERE WAS SCAPULAR NOTCHING, INSTABILITY AND SEVERE WEAR OF THE LINER. FROM THE RADIOGRAPHIC IMAGE, THE SCAPULAR NOTCHING IS VISIBLE AND THE HUMERUS APPEARS IN A SUBOPTIMAL POSITION. THE POST-OP CONSTRUNCT DID NOT PROVIDE THE NECESSARY LATERALIZATION, HENCE THE INSTABILITY AND THE NOTCHING. THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    AT 1 YEAR 11 MONTHS FROM PRIMARY THE PATIENT WAS REVISED DUE TO SCAPULAR NOTCHING, INSTABILITY AND SEVERE WEAR OF THE LINER. ALL COMPONENTS WERE REVISED AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665652 SHOULDER SYSTEM GLENOIDSPHERE 32XØ24.5 PHX MEDACTA INTERNATIONAL SA 04.01.0178 189863A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention