BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5

    MDR report key: 3191698 · Received June 26, 2013

    Report

    Report Number
    0002249697-2013-02079
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT HAS BEEN REPORTED UNDER MFR REPORT FOR REPORT #0002249697-2013-02006.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT A MALE PATIENT RECEIVED AN ACCOLADE STEM, 36MM LFIT HEAD, TRIDENT SHELL AND X3 POLY LINER IN 2011 DURING A PRIMARY TOTAL HIP ARTHROPLASTY. THE SURGEON REPORTED THAT THE PATIENT HAS NOW PRESENTED WITH SYMPTOMS OF TROCHANTERIC BURSITIS AND ALSO HAS RAISED METAL ION LEVELS. THE SURGEON REPORTED THAT HE INTENDS TO REVISE THE PATIENT ON (B)(6) 2013 DUE TO THE PERSONAL CIRCUMSTANCES OF THE PATIENT. THE SURGEON REPORTED THAT HE SUSPECTS THERE IS WEAR ON THE INSIDE OF THE TAPER HEAD JUNCTION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT A MALE PATIENT RECEIVED AN ACCOLADE STEM, 36MM LFIT HEAD, TRIDENT SHELL AND X3 POLY LINER IN 2011 DURING A PRIMARY TOTAL HIP ARTHROPLASTY. THE SURGEON REPORTED THAT THE PATIENT HAS NOW PRESENTED WITH SYMPTOMS OF TROCHANTERIC BURSITIS AND ALSO HAS RAISED METAL ION LEVELS. THE SURGEON REPORTED THAT HE INTENDS TO REVISE THE PATIENT ON (B)(6) 2013 DUE TO THE PERSONAL CIRCUMSTANCES OF THE PATIENT. THE SURGEON REPORTED THAT HE SUSPECTS THERE IS WEAR ON THE INSIDE OF THE TAPER HEAD JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291751 ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 14575401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other