BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS LIPPED TIBIA INSERT MED 13

    MDR report key: 3897196 · Received June 26, 2014

    Report

    Report Number
    0002249697-2014-02436
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K012172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PATIENT WOULD NOT RELEASE.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING BASEPLATE LOOSENING INVOLVING A PS LIPPED TIBIA INSERT MED 13 WAS REPORTED. IT WAS REPORTED DOCTOR FOUND THAT TIBIAL PLATE WAS LOOSE. NO ALLEGATIONS WERE MADE REGARDING THE INSERT. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FOUND THAT TIBIAL PLATE WAS LOOSE. HE REMOVED ALL COMPONENTS AND REPLACED THEM WITH THE TRIATHLON TS SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FOUND THAT TIBIAL PLATE WAS LOOSE. HE REMOVED ALL COMPONENTS AND REPLACED THEM WITH THE TRIATHLON TS SYSTEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373367 PS LIPPED TIBIA INSERT MED 13 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R