BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 44MM ID INTL COCR LINER 56MM

    MDR report key: 8778698 · Received July 10, 2019

    Report

    Report Number
    3005975929-2019-00269
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 25, 2019
    Report Date
    March 2, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [253493 SUMMARY.PDF]

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A PRIMARY R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2010, THE PATIENT EXPERIENCED ADVERSE LOCAL TISSUE REACTION WITH JOINT EFFUSION, PAIN, HIGH METAL ION LEVELS AND METALLOSIS, SYNOVITIS AND FOCAL PSEUDOTUMOR FORMATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT; THE R3 44MM ID INTL COCR LINER 56MM AND BHR MODULAR HEAD 44MM WERE EXPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019 IN A GOOD CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAINFUL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572709 R3 44MM ID INTL COCR LINER 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08LW20242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R 71306616, SYN. POROUS FEM. STEM, 09MM08980.| 71331856, R3 0 HOLE ACET. SHELL 56MM, 09BM00071.| 71336500, REF. THREAD HOLE COVER, 09MM02837.| 74222100, MODULAR SLEEVE -4MM12/14, 09KT36427.| 74222144, BHR MOD. HEAD 44MM, 09BW21670.| MODULAR HEAD 44MM 74222144/ LOT 09BW21670.| SLEEVE -4MM 12/14 74222100/LOT 09KT36427.