BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON-ASYMMETRIC PATELLA A29MM(S/I) X 9MM

    MDR report key: 1833114 · Received September 9, 2010

    Report

    Report Number
    9610726-2010-00297
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    February 28, 2007
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN OPERATIVE SITE ADVERSE EVENT WAS REPORTED FOR "QUESTIONABLE IRREGULARITY TO THE MOST LATERAL MARGIN OF THE PATELLAR INSERT," THE TREATMENT WAS TRIAL OF IMMOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-ASYMMETRIC PATELLA A29MM(S/I) X 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LT606

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention