BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE-CEMENTED

    MDR report key: 1435699 · Received August 6, 2009

    Report

    Report Number
    2249697-2009-00471
    Event Type
    Injury
    Date Received
    August 6, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 9, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. THE HOSPITAL DISCARDED THE EXPLANTED DEVICE(S). ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT. -TRIATHLON-CR FEMORAL COMPONENT CEMENTED #3 RIGHT CAT# 5510-F-302; LOT SE7HB, TRIATHLON-CR TIBIAL INSERT #3-11MM, CAT# 5530-P-311; LOT LAH558, TRIATHLON-ASYMMETRIC PATELLA A32MM(S/I*) X 10MM CAT# 551-L-320; LOT LAL142, SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE CAT# 6197-9-001; LOT 0473S015. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REMOVAL OF IMPLANT DUE TO INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PRIM TIB BASEPLATE-CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA WKIH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention