BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT CEMEMTED #5 RIGHT

    MDR report key: 1823792 · Received August 30, 2010

    Report

    Report Number
    9610726-2010-00264
    Event Type
    Other
    Date Received
    August 30, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CLINICAL AFFAIRS DEPARTMENT REPORTED THAT DURING THE TRIATHLON CLINICAL TRIAL, THERE WAS COMPLICATIONS FOLLOWING PRIMARY SURGERY ON (B)(6) 2009 WHICH CONSISTED OF ACUTE RENAL FAILURE AND A BOWEL OBSTRUCTION. IT IS FURTHER REPORTED THAT BOTH CONDITIONS RESPONDED TO CONSERVATIVE MEDICAL MANAGEMENT. IT IS FURTHER REPORTED THAT THE PATIENT HAD A PROLONGER LENGTH OF HOSPITAL STAY OF 10 DAYS. IT IS FURTHER REPORTED THAT THIS INFORMATION WAS HIGHLIGHTED AT THE ONE YEAR FOLLOW-UP TIME FRAME AS THE EVENT WAS NOT PICKED UP SOONER DUE TO THE 3 MONTH FOLLOW-UP APPOINTMENT BEING MISSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENT CEMEMTED #5 RIGHT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SMD3Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other