BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS LIPPED TIBIA INSERT MED 11

    MDR report key: 2162195 · Received July 7, 2011

    Report

    Report Number
    9616680-2011-00448
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K012172
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT STEPPED ON SOMETHING THAT CAUSED AN INFECTION WHICH RADIATED TO HIS KNEE SO HIS KNEE REPLACEMENT WAS REVISED. THE SURGEON IRRIGATED THE AREA, ADDED ANTIBIOTICS AS WELL AS A TUBE/DRAIN FOR FUTURE ANTIBIOTICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS LIPPED TIBIA INSERT MED 11 IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention