BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2233991 · Received August 31, 2011

    Report

    Report Number
    2249697-2011-01302
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT CAME TO OFFICE COMPLAINING OF KNEE PAIN ON (B)(6) 2011. STATED PAIN HAS BEEN WORSENING OVER LAST SEVERAL MONTHS. BONE SCANS REVEALED LUCENCY AROUND TIBIAL COMPONENT. PLAN TO REVISE ALL COMPONENTS. TIBIA CAME OFF EASILY. TRIATHLON TS IMPLANTS USED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL CONFIDENTIALITY POLICY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T02L40

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention