BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVON PAT/FEM JOINT EX SMALL

    MDR report key: 1942443 · Received December 22, 2010

    Report

    Report Number
    9610726-2010-00489
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 10, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRR
    PMA / PMN Number
    K041160
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA FAX THAT A PT UNDERWENT A SURGICAL PROCEDURE DUE TO A DEGENERATIVE PATELLAR-FEMORAL ARTHROPATHY OF THE RIGHT KNEE OF (B)(6) 2009. FOLLOWING THE OPINION OF THE SURGEON, THE PROSTHESIS WAS EXPLANTED ON (B)(6) 2010, BECAUSE OF AN INTOLERANCE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVON PAT/FEM JOINT EX SMALL IMPLANT KRR STRYKER ORTHOPAEDICS LIMERICK NA SBYRC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention