BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSYS LNR AOX N 52X40

    MDR report key: 24116337 · Received January 20, 2026

    Report

    Report Number
    1818910-2026-01131
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    January 31, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295501381
    PMA / PMN Number
    K221636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DEPUY SYNTHES (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 472252040, LOT - 4831329) 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 A SEARCH OF THE DEPUY SYNTHES (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 472252040, LOT - 4831329) COMBINATION. 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 PATIENT SUFFERED FROM INFECTION DUE TO IMPLANT. DOI-(B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180075 EMSYS LNR AOX N 52X40 HIP IMPLANT : ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US 4831329 10603295501381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention