BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON SYMMET DURATION 36X10M

    MDR report key: 2980354 · Received February 27, 2013

    Report

    Report Number
    0002249697-2013-00792
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    October 1, 2006
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRR
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MEDICAL RECORDS BY A CLINICIAN CONCLUDED THAT NO DETERMINATION CAN BE MADE REGARDING THE CAUSE OF THE APPARENT SHEARING OFF OF THE PATELLAR COMPONENTS AT THE BASE OF THE THREE CEMENTED POLY PEGS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A FRACTURED PATELLA INVOLVING A DURACON SYMMET DURATION 36X10M WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT NOTED ¿THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THESE CLINICAL SITUATIONS." DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS AN EVALUATION OF THE REPORTED DEVICE IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE IMPLANT BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE IMPLANT BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE IMPLANT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83761 DURACON SYMMET DURATION 36X10M IMPLANT KRR STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R