BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK/5 NAVIGATION PIN 3MMX100MM

    MDR report key: 1171094 · Received September 19, 2008

    Report

    Report Number
    8010177-2008-00064
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    August 14, 2006
    Report Date
    August 14, 2006
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Removal / Correction Number
    18117556/5/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. A RECALL WAS INITIATED ON THE INSTRUCTIONS FOR USE FOR THESE PINS. THE INSTRUCTIONS FOR USE WAS REVISED TO INCLUDE NEW WARNINGS REGARDING ASPECTS OF PIN PLACEMENT IN THE FEMUR AND TIBIA.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT SIX WEEKS POST RIGHT REVISION TKA, PT PRESENTED WITH MILD TIBIAL PAIN INCLUDING TENDERNESS AT THE PIN SITE AT THE TIBIAL CREST. ALTHOUGH X-RAYS INITIALLY WERE NEGATIVE FOR FRACTURE, AN MRI SHOWED EDEMA MID TIBIA BELOW THE PROSTHESIS AND FURTHER EXAMINATION AT THREE, FIVE, AND EIGHT MONTHS SHOWED EVIDENCE OF A FRACTURE. THE FRACTURE WAS TREATED BY NON-OPERATIVE MEANS SUCH AS PROTECTED WEIGHT BEARING, BRACING AND EXTERNAL BONE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK/5 NAVIGATION PIN 3MMX100MM STEREOTAXIC INSTRUMENT HAW STRYKER NAVIGATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention