BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4130394 · Received September 30, 2014

    Report

    Report Number
    0002249697-2014-03698
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    June 2, 2012
    Report Date
    September 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENT WAS CONFIRMED FROM MEDICAL RECORDS. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: ¿A MATERIAL ANALYSIS REPORT OF THE FRACTURE SURFACES OF THIS BROKEN STEM WOULD LIKELY DEMONSTRATE A FATIGUE FRACTURE AT THE JUNCTION OF THE LOOSE PROXIMAL AND WELL-FIXED DISTAL SEGMENTS, POSSIBLY INITIATED AT A DAMAGE SITE FROM A PREVIOUS UNSUCCESSFUL SURGICAL ATTEMPT TO REMOVE THE COMPONENT. THERE IS NO EVIDENCE THAT THIS CLINICAL PICTURE OF INFECTION, LOOSENING, AND MULTIPLE SURGERIES OF THE RIGHT KNEE RESULTED FROM FACTORS OF FAULTY STRYKER PROSTHETIC COMPONENT DESIGN, MANUFACTURING OR MATERIALS.¿

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN POLY. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT KNEE DUE TO OPERATIVE FIXATION. POLY EXCHANGE WAS DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT KNEE DUE TO OPERATIVE FIXATION. POLY EXCHANGE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609244 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention