BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVON PAT/FEM JOINT EX SMALL

    MDR report key: 3936187 · Received July 15, 2014

    Report

    Report Number
    0002249697-2014-02718
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING REVISION OF AN AVON FEMUR DUE TO WEAR OF THE FEMORAL CONDYLES WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION INDICATED THE JOINT INDICATED NO NOTABLE SIGNS OF WEAR OR DAMAGE. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: NO CLINICAL OR PAST MEDICAL HISTORY, NO OPERATIVE REPORTS, AND NO DESCRIPTION OF THE DURATION, NATURE OR SEVERITY OF THE PAIN INDICATING THE REVISION SURGERY ARE AVAILABLE. THE MATERIAL ANALYSIS REPORT APPEARS TO HAVE RULED OUT FACTORS OF FAULTY MANUFACTURING OR MATERIALS AS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THE PAIN AND REVISION OF THE AVON FEMUR WAS DUE TO INCREASED WEAR OF THE FEMORAL CONDYLES, I.E. DISEASE PROGRESSION. ANALYSIS OF THE RETURNED COMPONENT INDICATED THERE WAS NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 5550-G-278, PATELLA 27MM, LOT CODE 883K; CAT 6197-9-001, SIMPLEX P WITH TOBRAMYCIN 1 PACK, LOT CODE MDQ021. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PER EMAIL UPDATE DATED 07-JUL-2014: SURGEON NOTED WARE ON THE PATELLA BUT NO MECHANICAL FAILURE. SURGEON INDICATED THAT THE PAIN WAS CAUSE BY NEW WARE ON THE FEMORAL CONDYLES WHICH LED TO A TOTAL JOINT REPLACEMENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATELLA FEMORAL IMPLANTS WERE REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412212 AVON PAT/FEM JOINT EX SMALL IMPLANT NPJ STRYKER ORTHOPAEDICS-MAHWAH SLK3S

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention