BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #3 L-CEM

    MDR report key: 2974874 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00761
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    March 1, 2012
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL DEVICES WERE REVIEWED BY A CONSULTING CLINICIAN WHO INDICATED MORE ALLERGIC AND DERMATOLOGIC WORKUP IS REQUIRED TO EVALUATE THIS CASE. THERE IS NO EVIDENCE OF FAULTY MANUFACTURING OR DESIGN BEING INVOLVED WITH THIS CASE, AND AN ALLERGIC REACTION TO THE COMPONENTS HAS NOT BEEN ENTIRELY RULED OUT. DEVICE HISTORY REVIEW INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO PREVIOUS REPORTED EVENTS FOR THIS LOT ID. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT:(B)(4), WAWA TRIATHLON SYMMETRIC X3 PATELLA.(B)(4), LCO506 X3 TRIATHLON CS INSERT #3 13MM. (B)(4), GGTU TRIATHLON PRIM TIB BASEPLATE - CEMENTED. AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S RASH. (B)(4): REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SHORTNESS OF BREATH AND A RASH ON HER LEFT KNEE. THIS RASH HAS SPREAD OVER HER BODY. DOCTORS BELIEVE THAT IT IS AN ALLERGIC REACTION FROM PATIENT'S KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SHORTNESS OF BREATH AND A RASH ON HER LEFT KNEE. THIS RASH HAS SPREAD OVER HER BODY. DOCTORS BELIEVE THAT IT IS AN ALLERGIC REACTION FROM PATIENT'S KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78533 TRIATHLON CR FEM COMP #3 L-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH S6J7L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other