BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURATION PATELLA LRG

    MDR report key: 2150612 · Received June 23, 2011

    Report

    Report Number
    9610726-2011-00217
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 6, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON, MR. (B)(6), REPORTED ON BEHALF OF HIS PT THAT AFTER HAVING HAD A VERY SUCCESSFUL KINEMAX REPLACEMENT FOR HIS LEFT KNEE ON THE (B)(6) 2004, THE PT BEGAN TO EXPERIENCE OCCASIONAL PAIN IN HIS KNEE ABOUT A YEAR AGO. HE ADDED THAT THE SYMPTOMS OCCUR APPROX. TWO OR THREE TIMES A WEEK, LAST FOR A FEW HOURS AND SETTLE WITH PARACETAMOL. HE FURTHER REPORTED THAT THEY APPEARED TO BE MECHANICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURATION PATELLA LRG IMPLANT HSX STRYKER ORTHOPAEDICS LIMERICK NA LH793

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention