BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 2062736 · Received April 13, 2011

    Report

    Report Number
    2249697-2011-00448
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    August 25, 2010
    Report Date
    March 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON-PRIM TIB BASEPLATE: CAT# 5520-B-500 LOT# ST43M. TRIATHLON-PS TIBIAL INSERT #5 - 9 MM: CAT# 5532-P-509 LOT# LBY170. TRIATHLON-ASYMMETRIC PATELLA A35MM(S/I) X 10MM CAT# 5551-L-350 LOT# LBY771. AT THE PRESENT TIME IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAY AND MEDICAL RECORDS) AND REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SHE IS IN PAIN ALL THE TIME. WHEN SHE WALKS SHE GETS SHOOTING PAIN THAT GOES DOWN HER LEG. SHE IS SHIFTING HER WEIGHT WHEN SHE WALKS. SHE BELIEVES HER KNEE WAS PART OF THE RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS FEM COMPONENT, CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA DHPL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other