BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF CENT HIP 49X28 BRN

    MDR report key: 23204096 · Received October 2, 2025

    Report

    Report Number
    1818910-2025-17019
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 14, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    PMA / PMN Number
    K812672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SEARCH OF THE MEDTECH ORTHOPEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<103549000>/LOT<D25041557> 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<103549000>/LOT<D25041557> COMBINATION. H11 ADDITIONAL NARRATIVE: ADDED: D10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S HIP STARTED TO DRAIN AFTER HAVING A HEMI HIP DONE ON (B)(6) 2025. SURGEON WAS CONCERNED JOINT WAS INFECTED. WANTED TO DO AN EXCHANGE OF THE BIPOLAR AND 28 MM HEAD ALONG WITH A WASHOUT. DOI-(B)(6) 2025. DOJ-(B)(6) 2025. AFFECTED SIDE-LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318079 SELF CENT HIP 49X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI KWY DEPUY ORTHOPAEDICS INC US D25041557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention