BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON PLASTIC PATELLA MED1

    MDR report key: 1871265 · Received October 13, 2010

    Report

    Report Number
    2249697-2010-01349
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910235
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DHR, COMPLAINT HISTORY AND PACKAGING INSERT REVIEW. EVAL SUMMARY: THE RESULTS OF THE INVESTIGATION INDICATE THAT THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON THE INFO PROVIDED. NEITHER THE EXPLANTED DEVICES NOR PT MEDICAL RECORDS OR X-RAYS WERE RETURNED FOR EVAL. REVIEW OF THE MFG DEVICE HISTORY RECORDS INDICATED NO EVIDENCE OF PROSTHETIC DESIGN, MFG, OR MATERIAL FACTORS AS BEING RESPONSIBLE FOR THE REPORTED EVENT. AS THE PATELLA WAS IMPLANTED IN SITU FOR OVER 14 YEARS, IT IS MOST LIKELY THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER ASSOCIATED WITH PT AND/OR CLINICAL FACTORS. THE PRODUCT EXPERIENCE REPORTING DATABASE (2004 - PRESENT) SHOWS THAT THERE HAVE BEEN NO ANY OTHER SIMILAR REPORTED EVENTS REGARDING THE REPORTED LOT OF PRODUCT. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATELLAR BUTTON IMPLANT LOOSENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON PLASTIC PATELLA MED1 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UOKVA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention