BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR FEMUR #3 LM/RL

    MDR report key: 2576038 · Received May 10, 2012

    Report

    Report Number
    2249697-2012-00584
    Event Type
    Injury
    Date Received
    May 10, 2012
    Date of Event
    April 23, 2012
    Report Date
    April 23, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071881
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO 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: CAT # 5620-B-301 LOT# ZLKDA DESCRIPTION: TRIATHLON PKR BASEPLATE #3 LM/RL. CAT # 5630-G-308 LOT# MHPH9M DESCRIPTION: TRIATHLON PKR INSERT X3 #3 LM/RL-8MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT HAD PKR PUT IN AND WAS DOING FINE UNTIL SHE SUSTAINED A FALL. SHE RUPTURED HER PCL AND HAS BEEN UNSTABLE WITH PAIN. THE PT'S PKR IMPLANTS WERE WELL FIXED WITH NO LOOSENING. WE REPLACED WITH TRIATHLON PS KNEE. DR. (B)(6) BELIEVES ALL HER PAIN WAS DUE TO HER FALL AND RUPTURE OF HER PCL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PKR FEMUR #3 LM/RL IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA WVBT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention