BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 19535374 · Received June 14, 2024

    Report

    Report Number
    3005180920-2024-00433
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 17, 2024
    Report Date
    June 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER BOTH GLENOSPHERE AND REVERSE METAPHYSIS SCREWS HAVE PARTIAL REMOVAL OF THE GREY COLOR TYPICAL OF THE TYPE-II ANODIZATION. THIS IS COMMONLY DUE TO FRICTION BETWEEN THE SCREW AND OUTER SURFACES (I.E., CENTRAL BORE OF THE GLENOSPHERE AND CENTRAL BORE OF THE REVERSE METAPHYSIS). THE CAUSE OF THE DIFFICULTY IN TIGHTENING THE SCREWS IS DETERMINED AS A MALALIGNMENT BETWEEN THE GLENOSPHERE AND THE BASEPLATE (LIKELY DUE TO THE GUIDE NOT BEING USED) AND BETWEEN THE REVERSE METAPHYSIS AND THE HUMERAL DIAPHYSIS. NO ACTION IS SUGGESTED. BATCH REVIEW PERFORMED ON 29 MAY 2024 LOT 2342015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2024. EXPIRATION DATE: 2029-01-31. 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 REVIEWS OF THE OTHER DEVICES INVOLVED IN THE COMPLAINT (PERFORMED ON 29 MAY 2024): REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2345662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2024. EXPIRATION DATE: 2029-03-05. 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 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT 2335014: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2024. EXPIRATION DATE: 2029-02-05. 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 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT 2335902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2023. EXPIRATION DATE: 2028-10-24. 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.

    Description of Event or Problem · 0

    IT WAS NOT POSSIBLE TO INSERT CORRECTLY THE SCREWS OF GLENOSPHERE AND METAPHYSIS DURING SURGERY. THE EVENT WAS LIKELY DUE TO SOFT TISSUE INTERPOSED BETWEEN BASEPLATE/GLENOSPHERE AND MISSING USE OF THE GLENOSPHERE GUIDE. FOR METAPHYSIS, IT WAS POSSIBLE THAT THE METAPHYSIS SCREW WAS DEFORMED BECAUSE IT WAS INSERTED WITH AN ANGLE AT FIRST. THE SURGEON REMOVED BONE AND SOFT TISSUE AROUND THE COMPONENTS, TAKE 2 SCREWS FROM DIFFERENT IMPLANTS, AND COMPLETED THE SURGERY SUCCESSFULLY. 1 HOUR OF DELAY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153550 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 2342015 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other