BEUDAMED
    FDA Adverse Event Injury Summary report: N

    56MM AND R3 ACETABULAR SHELL

    MDR report key: 7880553 · Received September 14, 2018

    Report

    Report Number
    MW5079817
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    October 20, 2016
    Report Date
    August 27, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I UNDERWENT A TOTAL HIP ARTHROPLASTY ON MY LEFT HIP ON (B)(6) 2011. THE IMPLANT WAS ALL SMITH & NEPHEW COMPONENTS IN A METAL-ON-METAL CONFIGURATION, INCLUDING THE FOLLOWING COMPONENTS: SMITHS & NEPHEW 56MM R3 ACETABULAR SHELL (REF NO. (B)(4), K092386), R3 COCR METAL LINER (REF NO. (B)(4), P040033 S006), AND COCR MODULAR FEMORAL (HEMI) HEAD (REF NO. (B)(4), K062408). ON (B)(6) 2016, I HAD A REVISION SURGERY OF THE LEFT HIP. THE HEAD AND CUP WERE REMOVED AND REPLACED. I WAS DIAGNOSED WITH "LEFT HIP MECHANICAL LOOSENING." THE DR WHO CHECKED THE INFECTION IN MY HIP HAD NEVER SEEN SO MUCH INFECTED FLUID BUILDUP BEFORE AN ENTIRE SYRINGE FULL OF FLUID. SEVERE HIP PAIN BEFORE REVISION SURGERY, UNABLE TO HANDLE MANUAL TRANSMISSION ON SEMI TRUCK. OCCASIONAL PAIN, CANNOT RUN OR JOG HYPO-THYROIDISM; 7412-2544 HEAD, LOT NO. 09AW21331 LINER 07HW13127 HEAD, UDI NO (B)(4) LINER; +(B)(4) HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716732 56MM AND R3 ACETABULAR SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED MBL SMITH & NEPHEW, INC.
    716793 R3 COCR METAL LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL / METAL RESURFACING NXT SMITH & NEPHEW, INC.
    716794 COCR MODULAR FEMORAL (HEMI) HEAD PROSTHESIS, HIP, HEMI, FEMORAL, METAL KWL SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S