BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT

    MDR report key: 2012951 · Received March 2, 2011

    Report

    Report Number
    9610726-2011-00053
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 8, 2010
    Report Date
    February 14, 2011
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AT PRESENT, THE CUSTOMER WHO REPORTED THIS EVENT IS UNABLE TO OBTAIN THE PT'S MEDICAL NOTES AS THEY ARE BEING HELD IN A CONSULTANT CLINIC. THE CUSTOMER WILL BE IN TOUCH AS SOON AS SHE IS IN RECEIPT OF THE PT'S RECORDS AND HAS FURTHER INFORMATION REGARDING THIS EVENT. THE CUSTOMER WILL ALSO BE IN TOUCH TO CONFIRM THE CORRECT PRODUCT CODE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE CLINICAL AFFAIRS DEPARTMENT THAT THERE HAS BEEN A SERIOUS ADVERSE EVENT AS PART OF THE TRIATHLON OUTCOMES STUDY THAT IS FOLLOWING THE OUTCOMES OF PTS WHO HAVE A TRIATHLON KNEE REPLACEMENT. THE CUSTOMER REPORTED THAT THE PT HAD A 3 YEAR F/U ON (B)(6) 2011. AT THE APPOINTMENT, THE PT REPORTED THAT THEY HAD BEEN TREATED FOR A SUSPECTED INFECTION OF THEIR TOTAL KNEE REPLACEMENT APPROX A YEAR AGO IN (B)(6) 2010. THE PT ADDED THAT THEY EXPERIENCED SWELLING OF THE KNEE AND THAT THEY WERE TREATED WITH REGULAR CONSULTANT APPOINTMENTS AND A TWO WEEK COURSE OF ANTIBIOTICS. THE CUSTOMER REPORTED THAT THIS RELIEVED THE PT'S SYMPTOMS AND NO FURTHER INTERVENTION WAS NECESSARY. HOWEVER, IT IS UNCLEAR WHETHER THE PT WAS OFFICIALLY ADMITTED TO HOSPITAL OR ONLY STAYED FOR THE DURATION OF THE INVESTIGATION THAT TOOK PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention