BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSYS SHL MLTHOLE 56

    MDR report key: 23141909 · Received September 25, 2025

    Report

    Report Number
    1818910-2025-16462
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    September 8, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LPH
    PMA / PMN Number
    K221636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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 ORTHOPAEDICS (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 471056900, LOT - 4811983) 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 ORTHOPAEDICS (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 471056900, LOT - 4811983) COMBINATION. H11 ADDITIONAL NARRATIVE: ADDED: D10 (CONCOMITANT).

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CONFIRMED HIP INFECTION. IMPLANTS WERE REMOVED AND SPACER WAS IMPLANTED. THERE WERE NO DELAYS OR COMPLAINTS. AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597060 EMSYS SHL MLTHOLE 56 HIP IMPLANT : ACETABULAR CUP LPH DEPUY IRELAND - 3015516266 4811983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DELTA CER HEAD 12/14 36MM +5.| EMSYS LNR AOX ELV 56-58X36.| PINN CAN BONE SCREW 6.5MMX20MM.| PINN CAN BONE SCREW 6.5MMX25MM.| PINN CAN BONE SCREW 6.5MMX45MM.| RECLAIM DISTAL TAPERED 15X140.| RECLAIM PRX BDY CONE 24X85.