BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X300MM X 1

    MDR report key: 2628791 · Received June 19, 2012

    Report

    Report Number
    9610622-2012-00267
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER (B)(4) DEPARTMENT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION. ASSOCIATED DEVICES: 3060-0090S , LAG SCREW, TI GAMMA3 10.5X90MM, LOT# K179134; 3003-0822S, SET SCREW, TI GAMMA3 8X17.5MM, LOT# K147270.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY "ON (B)(6) 2009, THE PT UNDERWENT THE IMPLANTATION OF A PROSTHETIC HIP AT (B)(6) MEDICAL CENTER." IT WAS FURTHER ALLEGED THAT, "IN OR ABOUT (B)(6) 2011, THE PT WAS IN THE PROCESS OF STEPPING OUT OF A VAN WHEN SHE LANDED HARDER ON HER RIGHT FOOT THAN SHE INTENDED. IN THE WEEKS FOLLOWING THE INCIDENT, THE PT DEVELOPED SEVERE PAIN IN AND AROUND HER HIP." IT WAS FURTHER ALLEGED THAT, "ON (B)(6) 2011, THE PT RETURNED TO (B)(6) MEDICAL CENTER, WHERE SHE UNDERWENT A REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X300MM X 1 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K572418

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R