BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21321419 · Received February 6, 2025

    Report

    Report Number
    3005180920-2025-00060
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JAN 2025. LOT 2413115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEPT-2024. EXPIRATION DATE: 2029-09-01. 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. ADDITIONAL IMPLANTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0111 HUMERAL REVERSE METAPHYSIS +9MM/0° (K170452) LOT. 2348169. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2024. EXPIRATION DATE: 2029-04-25. 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 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT. 189730. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANALYSIS PERFORMED BY R&D PROJECT MANAGER. THE HUMERAL REVERSE METAPHYSIS (REF. (B)(4)) IS DESIGNED TO BE COUPLED WITH THE CHOSEN HUMERAL DIAPHYSIS BY MEANS OF A FIXATION SCREW THAT, WHEN THREADED, EASILY ALLOWS THE COMPONENT TO CAME IN CONTACT WITH THE DIAPHYSIS. THE COUPLING, HOWEVER, IS GUARANTEED NOT BY THE HUMERAL REVERSE METAPHYSIS SCREW, BUT BY THE PRESSFIT BETWEEN THE REVERSE METAPHYSIS MICROTHREADED PORTION OF THE THREAD AND THE Ø8H7 HOLE ON THE HUMERAL DIAPHYSIS. A DIFFICULTY IN ASSEMBLING THE TWO COMPONENTS MAY BE RELATED TO AN IMPERFECT THREAD OF THE REVERSE METAPHYSIS SCREW OR ON THE HUMERAL DIAPHYSIS, OR TO THE TORQUE LIMITING SCREWDRIVER. WITH THE PRESENT INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A CLEAR ROOT CAUSE OF THE EVENT. HOWEVER, GIVEN THAT THE SURGEON WAS ABLE TO COUPLE THE REVERSE METAPHYSIS WITH THE HUMERAL DIAPHYSIS BY MEANS OF IMPACTION WITH A MULLET, AND AS THE PRESSFIT GUARANTEES THE COUPLING BETWEEN THE IMPLANTS, EVEN IF THE SCREW HAS NOT BEEN IMPLANTED, NO ADDITIONAL RISKS RELATED TO THE COUPLING OF THE IMPLANTS RESULT FROM THE DEVIATION FROM THE STANDARD SURGICAL TECHNIQUE. THE IMPLANTS ARE NOT SUBJECT TO ANY TRACTION FORCES, BUT ONLY COMPRESSION BETWEEN THEM.

    Description of Event or Problem · 0

    DURING THE REVISION SHOULDER SURGERY, WHEN THE SURGEON WAS TRYING TO IMPLANT THE REVERSE METAPHYSIS, THE METAPHYSIS SCREW WOULD NOT THREAD DOWN. THE SURGEON USED ANOTHER METAPHYSIS AND STILL WAS UNABLE TO USE THE METAPHYSIS SCREW. TO COMPLETE THE SURGERY, THE SURGEON MATED THE 2 PIECES TOGETHER AND IMPLANTED THE POLY. THE ULTIMATE FINAL CONSTRUCT APPEARED SOLID, WITH NO GAP, AND THE PATIENT WAS CLOSED PER USUAL MANNER. THE SURGEON WAS INFORMED THAT THE SYSTEM IS DESIGNED TO UTILIZE THE METAPHYSIS SCREW BUT EXPLAINED THAT WAS NOT AN OPTION DUE MULTIPLE ATTEMPTS TO THREAD IT DOWN THAT WERE NOT SUCCESSFUL. THERE WAS A 25-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919881 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2413115 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other