BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #4

    MDR report key: 3071397 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01356
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE RETURNED ACCOLADE STEM SHOWS NO SIGNS OF BONE ON-GROWTH ON THE PROXIMAL COATED AREA. THERE ARE SHINY WEAR MARKS ON THE COATED AREA WHICH WOULD INDICATE MICRO MOTION DURING IN-VIVO USAGE. THERE ARE MINOR SCRATCH MARKS ON THE NECK AND PROXIMAL AREA OF THE COATED REGION, WHICH WERE LIKELY CAUSED DURING EXPLANTATION, HOWEVER, THERE IS NO EVIDENCE OF IMPINGEMENT. MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT AS FOLLOWS: IN THIS YOUNG, LARGE, VERY ACTIVE MALE PATIENT, NO DETERMINATION CAN BE MADE REGARDING THE CAUSE OF THE APPARENT FAILURE OF BIOLOGIC FIXATION OF THE FEMORAL COMPONENT REQUIRING REVISION EIGHT YEARS POST-OPERATIVE. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    LEFT TOTAL HIP REVISION. THE SURGEON STATED THAT PATIENT WAS HAVING PAIN IN THE PREVIOUSLY REPLACED HIP, X-RAYS WERE OBTAINED, LABS DRAWN, AND REVISION TOTAL HIP WAS SCHEDULED. DURING REVISION PROCEDURE, UPON THE SURGEON ENTERING THE HIP JOINT CAPSULE AND DISLOCATING THE HIP, THE SURGEON STATED THAT THE HIP STEM WAS LOOSE. THE SURGEON REPLACED THE EXPLANTED ACCOLADE STEM WITH A RESTORATION MODULAR STEM AND ALSO REMOVED THE ALUMNIA CERAMIC LINER AND REPLACED WITH AN MDM.

    Description of Event or Problem · 1

    LEFT TOTAL HIP REVISION. THE SURGEON STATED THAT PATIENT WAS HAVING PAIN IN THE PREVIOUSLY REPLACED HIP, X-RAYS WERE OBTAINED, LABS DRAWN, AND REVISION TOTAL HIP WAS SCHEDULED. DURING REVISION PROCEDURE, UPON THE SURGEON ENTERING THE HIP JOINT CAPSULE AND DISLOCATING THE HIP, THE SURGEON STATED THAT THE HIP STEM WAS LOOSE. THE SURGEON REPLACED THE EXPLANTED ACCOLADE STEM WITH A RESTORATION MODULAR STEM AND ALSO REMOVED THE ALUMNIA CERAMIC LINER AND REPLACED WITH AN MDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173069 ACCOLADE PLUS TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 9656303

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O| R