BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20704005 · Received November 18, 2024

    Report

    Report Number
    3005180920-2024-01001
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 15, 2024
    Report Date
    December 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. CLINICAL EVALUATION DURING SURGERY, WHEN THE METAPHYSIS WAS COUPLED IN THE BACK-TABLE WITH THE DIAPHYSIS, A GAP OF ABOUT 2 MM WAS NOTICED. ACCORDING TO THE REPORT, THE GAP, EVEN IF SMALLER, REMAINED AFTER HAMMERING THE METAPHYSIS USING AN INSTRUMENT. HOWEVER, THIS GAP IS NOT VISIBLE IN THE RADIOGRAPHIC IMAGE. SINCE THE CONNECTION FELT STABLE, THE SURGEON DECIDED TO IMPLANT THEM. NO CONSIDERATION CAN BE MADE FROM THE IMAGES RECEIVED. ADDITIONALLY, LOOKING AT THE RADIOGRAPHIC IMAGE, THE GLENOSPHERE SEEMS TO BE NOT FULLY SEATED WITH THE BASEPLATE. 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 28 OCTOBER 2024: LOT 2406929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2024. EXPIRATION DATE: 2029-JUL-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT 2349408: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2024. EXPIRATION DATE: 2029-FEB-06. 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

    THE METAPHYSIS COULD NOT BE ASSEMBLED WITH THE DIAPHYSIS, A GAP OF ABOUT 2 MM REMAINED. THE METAPHYSIS WAS HAMMERED (NOT DIRECTLY BUT USING AN INSTRUMENT), BUT A GAP, EVEN IF SMALLER, REMAINED. THE CONNECTION FELT STABLE, SO THE SURGEON DECIDED TO IMPLANT THEM. DEVICES WERE COUPLED IN BACKTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596006 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2406929 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Other