BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20819351 · Received December 2, 2024

    Report

    Report Number
    3005180920-2024-00992
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIMULATION TEST RESULTS RECEIVED ON 9 DEC 2024. SIMULATION TEST RESULTS: A CUSTOM FATIGUE TEST REPRODUCING THE CONDITIONS (IN-VITRO) OF THE REPORTED COMPLAINT WAS PERFORMED TO ASSESS THE POTENTIAL SYSTEM FAILURE. THE ASSEMBLY REACHED A TOTAL OF 10M CYCLES WITHOUT BREAKAGE OR FAILURE. ALTHOUGH NO ROOT CAUSE CAN BE IDENTIFIED, THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 NOVEMBER 2024. LOT: 2245710: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2023. EXPIRATION DATE: 2028-APR-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. THE ISSUE IS UNDER INVESTIGATION BY MEDACTA HIP R&D PROJECT MANAGER. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 12 NOVEMBER 2024 FOR REVERSE SHOULDER SYSTEM 04.01.0181 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 8 (K180089) LOT: 2349407, LOT: 2349407: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2024. EXPIRATION DATE: 2029-FEB-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. BATCH REVIEW PERFORMED ON 12 NOVEMBER 2024 FOR REVERSE SHOULDER SYSTEM 64.01.9002 DOUBLE ECCENTER/REVERSE METAPHYSIS SCREW LOT: 2213108, LOT: 2400625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TWO SIMILAR CASES HAVE BEEN REPORTED ON THE SAME SEMIFINISHED LOT.

    Description of Event or Problem · 0

    WHEN ASSEMBLING THE METAPHYSIS AND DIAPHYSIS, A GAP REMAINED. THE IMPACTOR REF. 04.01.10.0560 IMPACTOR FOR ECCENTRIC REVERSE METAPHYSIS WAS USED AND THE SCREW COULD BE FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304837 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2245710 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| O