BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT SZ10 135 HIGH COL

    MDR report key: 22998411 · Received September 8, 2025

    Report

    Report Number
    1818910-2025-15420
    Event Type
    Injury
    Date Received
    September 8, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MEH
    UDI-DI
    10603295455295
    PMA / PMN Number
    K192946
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SEARCH OF THE MEDTECH ORTHOPEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<L971110>/LOT<4699603> COMBINATION. 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 SEARCH OF THE MEDTECH ORTHOPEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<L971110>/LOT<4699603> COMBINATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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. H11 ADDITIONAL NARRATIVE: 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 THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA FOR OA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SALES REP WAS INFORMED THAT THE PATIENT IS SUSPECTED OF HAVING A DISLOCATION AND INFECTION, THEREFOR REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915746 CORAIL AMT SZ10 135 HIGH COL CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM MEH DEPUY ORTHOPAEDICS INC US 4699603 10603295455295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention