BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE ORIENTATION GUIDE

    MDR report key: 20751188 · Received November 21, 2024

    Report

    Report Number
    1818910-2024-24336
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 13, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    PXH
    UDI-DI
    10603295116592
    PMA / PMN Number
    K170748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 230795000, LOT: 2753167 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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 MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 230795000, LOT: 2753167 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2024 THAT METAL TAB ON GLENOSPHERE ORIENTATION GUIDE BROKE OFF WHILE TRYING TO POSITION THE GLENOSPHERE ECCENTRICITY. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708005 GLENOSPHERE ORIENTATION GUIDE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES PXH DEPUY ORTHOPAEDICS INC US 2753167 10603295116592

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male