BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20746385 · Received November 21, 2024

    Report

    Report Number
    3005180920-2024-00977
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 24, 2024
    Report Date
    December 17, 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
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 NOVEMBER 2024. LOT: 2406928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2024. EXPIRATION DATE: 2029-07-22. 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 28 OCTOBER 2024: REVERSE SHOULDER SYSTEM 04.01.0004 STD HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K170910) LOT: 2338967: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2023. EXPIRATION DATE: 2028-11-20. 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. REVIEW FOR REVERSE SHOULDER SYSTEM 04.01.0176 DOUBLE ECCENTER / REVERSE METAPHYSIS SCREW (K170452) LOT: 183538A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2024. EXPIRATION DATE: 2028-05-23. 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. THE DEVICES RECEIVED ARE UNDER INVESTIGATION BY MEDACTA HIP R&D PROJECT MANAGER.

    Additional Manufacturer Narrative · 0

    THE PIECES RETURNED ON 19 NOVEMBER 2024 BUT THE VISUAL INSPECTION REQUIRED A DEEP INVESTIGATION CORRECTIONS: -B1 -B2 -D8 TO BE DELETED -D9 -H3 -H8 VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE HUMERAL REVERSE METAPHYSIS DOES NOT DISPLAY ANY SIGN OF DAMAGE OR WEAR ON ITS PEG. THE LATERAL PIN IS CORRECTLY ASSEMBLED AND ORIENTED. THERE ARE NO SIGNS OF PAST ASSEMBLY. THE M8 THREADED HOLE DOES NOT PRESENT ANY SIGN OF USE OR WEAR. THE REVERSE METAPHYSIS SCREW DISPLAYS ITS FIRST 1.5 THREADS WEARED. THE COATING HAS BEEN REMOVED FROM THE 5TH AND 6TH THREADS. THERE ARE NO LINES ON ITS CYLINDRICAL PORTION. THE SCREW'S UNDERHEAD AND THE EDGE AROUND THE HEAD ARE LIGHTLY WEARED. THE TORX CONNECTION DOES NOT DISPLAY ANY SIGN OF WEAR OR USAGE. THE PIECE WAS MEASURED ACCORDING TO THE CONTROL INSTRUCTIONS. ALL CRITICAL AND FUNCTIONAL QUOTES HAVE BEEN FOUND IN TOLERANCE. THE METAPHYSIS AND ITS SCREW HAVE BEEN ASSEMBLED WITHOUT ISSUES OR REMAINING GAP WITH TWO DIFFERENT HUMERAL STANDARD DIAPHYSES, A SIZE 10 AND A SIZE 6. IT IS NOT POSSIBLE TO IDENTIFY THE EVENT ROOT CAUSE. SIMULATION TEST: 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.

    Description of Event or Problem · 0

    REGULAR REVERSE SHOULDER SURGERY, EVERYTHING WENT WELL UNTIL THE ASSEMBLY OF THE HUMERAL STEM (04.01.0004 - 2338967) AND THE REVERSE METAPHYSIS (04.01.0110 - 2406928). THE SURGEON USED THE BACKTABLE ASSEMBLY CONSTRUCT TO ASSEMBLE THE STEM AND METAPHYSIS, BUT THE SCREW COULD NOT CATCH THE THREAD OF THE STEM (THE METAPHYSIS COULD NOT BEEN COMPRESSEN ONTO THE STEM). THE SURGEON DECIDED TO USE ANOTHER DOUBLE ECCENTER/REVERSE METAPHYSIS SCREW WHICH WAS AVAILABLE (04.01.0176 - 183538A), BUT ALSO THE NEW SCREW COULD NOT SOLVE THE ISSUE. AFTER THAT THEY OPENED A NEW METAPHYSIS (04.01.0110 - 2401277) WHICH WORKED FINE, THE ASSEMBLY WAS SUCCESSFUL AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012841 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2406928 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R