BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-CR FEMORAL COMPONENTCEMENTED #4 LEFT

    MDR report key: 2162211 · Received July 7, 2011

    Report

    Report Number
    9610726-2011-00238
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    December 20, 2007
    Report Date
    June 21, 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
    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. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 5520-B-400 LOT # SE8DA DESCRIPTION: TRIATHLON PRIM TIB BASEPLATE - CEMENTED. CAT # 5530-P-409 LOT # LAX541 DESCRIPTION: TRIATHLON-CR TIBIAL INSERT #4 - 9 MM. CAT # 5551-L-299 LOT # LAT528 DESCRIPTION: TRIATHLON-ASYMMETRIC PATELLA A29MM(S/I*) X 9MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EVENT.

    Description of Event or Problem · 1

    A SERIOUS ADVERSE EVENT REPORT WAS SUBMITTED BY CLINICAL RESEARCHER. CLINICAL RESEARCHER REPORTED THAT THE PATIENT, WHO WAS TAKING PART IN THE (B)(4) OUTCOMES CLINICAL STUDY, HAD A PRIMARY LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2007. CLINICAL RESEARCHER FURTHER REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2011 AS THEY WERE SUFFERING FROM PAIN, INTERNAL ROTATION OF TIBIAL AND FEMORAL COMPONENTS AND PATELLA MALTRACKING WITH PREVIOUS ATTEMPT AT SOFT TISSUE STABILISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-CR FEMORAL COMPONENTCEMENTED #4 LEFT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA SFB4H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention