BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVON PAT/FEM JOINT SML

    MDR report key: 3970121 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02931
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRR
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A AVON PAT/FEM JOINT SML WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW. THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. THE REPORTED EVENT NOTED PATIENT PRESENTED WITH KNEE PAIN SO SURGEON REMOVED LISTED IMPLANT AND PLACED NEW FEMORAL COMPONENT. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH KNEE PAIN SO THE SURGEON REMOVED LISTED IMPLANT AND PLACED NEW FEMORAL COMPONENT. IT WAS A LEFT KNEE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH KNEE PAIN SO THE SURGEON REMOVED LISTED IMPLANT AND PLACED NEW FEMORAL COMPONENT. IT WAS A LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446920 AVON PAT/FEM JOINT SML IMPLANT KRR STRYKER ORTHOPAEDICS-MAHWAH S98YS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention