BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE LINER TRIAL 40+0 R

    MDR report key: 19190450 · Received April 26, 2024

    Report

    Report Number
    1818910-2024-09177
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 16, 2024
    Report Date
    April 26, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    HWT
    UDI-DI
    10603295547396
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE LOT CODE PROVIDED IS NOT A VALID FINISHED GOODS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER RESPECTING THE HUMERAL HEAD AND IMPLANTING THE TRIAL STEM THE SURGEON SIZED THE HEAD RESECTION, SNAPPED THE ADAPTER AT C AND TURNED CLOCKWISE TO H OFFSET. WHEN WENT TO PLACE FROM TRIALING IT CAME LOOSE. WHEN BROUGHT TO BACK TABLE IT WAS NOTICED SMALL TEETH LIKE PIECES INSIDE OF HEAD WERE SNAPPED OFF. THE PROCESS WAS DONE AGAIN WITH ONE SIZE UP HUMERAL HEAD, THE SAME THING HAPPENED. HE THEN MOVED ONTO PREPARING THE GLENOID AND ONCE PREPARED HE DECIDE ON A REVERSE. HE HAD NO ISSUES WITH BASEPLATE OR TRIAL GLENOSPHERE. HE ALIGNED THE LINES ON THE +0 SHELL TRIAL AND THE 40+0R POLY AND AN AUDIBLE SNAP WAS HEARD. HE THEN PLACED THAT CONSTRUCT ON THE STEM AND THE POLY WOULD NOT STAY SNAPPED IN PLACE AND DISSOCIATED ONCE THROUGH TRIALING THROUGH ROM THUS CREATING A MINOR DELAY IN SURGICAL PROCEDURE. DOCTOR WAS SATISFIED WITH OVERALL RANGE OF MOTION AND X-RAYS OF OVERALL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122259 REVERSE LINER TRIAL 40+0 R SHOULDER INSTRUMENT - HUMERAL TRIAL HWT DEPUY IRELAND - 3015516266 10332504 10603295547396

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male