BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 5013798 · Received August 19, 2015

    Report

    Report Number
    0002249697-2015-02725
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    May 1, 2014
    Report Date
    July 23, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN 36MM COCR HEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. OTHER TEXT : NOT AVAILABLE

    Description of Event or Problem · 1

    THIS EVENT PERTAINS TO THE PATIENT'S RIGHT HIP. A (B)(6) FEMALE PRESENTED TO OUTPATIENTS WITH BILATERAL THIGH PAIN IN (B)(6) 2013. SHE HAD UNDERGONE STAGED BILATERAL HIP REPLACEMENTS FOR OSTEOARTHRITIS. BOTH HIPS WERE REPLACED WITH 36MM COCR ON POLYETHYLENE ACCOLADE-TRIDENT THR'S. THE RIGHT HIP WAS REPLACED IN 2011 AND THE LEFT A YEAR LATER. 6 MONTHS AFTER THE LEFT THR BOTH HIPS BECAME PAINFUL. THE PATIENT UNDERWENT REVISION RIGHT THR IN (B)(6) 2014 TO A SIZE 12 HIGH OFFSET JRI STEM, WITH STANDARD 36 CERAMIC HEAD, SIZE 56 LIMA SHELL WITH 36MM ID CERAMIC LINER. BACKGROUND: IMMEDIATE FINDINGS: RADIOGRAPHS DEMONSTRATED LYSIS OF THE FEMORAL COMPONENT BILATERALLY (GRUEN ZONES 1 & 7). INFLAMMATORY MARKERS WERE NORMAL. MULTIPLE BIOPSIES DEMONSTRATED NO GROWTH UNDER MICROSCOPY, CULTURE AND STAINING. CRP WAS 2MG/DL, COBALT 140NMOL/L AND CHROMIUM 12.1NMOL/L. MRI OF BOTH HIPS DEMONSTRATED LARGE VOLUME TROCHANTERIC FLUID COLLECTIONS BILATERALLY (OXFORD TYPE II )[6]. INITIAL ION LEVELS SHOWED A COBALT LEVEL OF 140NMOL/L WHICH WERE REPEATED AND SHOWED AGAIN AN ELEVATED COBALT 161NMOL/L AND CHROMIUM 12.1NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547579 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R