BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 3953739 · Received July 23, 2014

    Report

    Report Number
    1644408-2014-00470
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMOVE A WORN KNEE TIBIAL INSERT THAT WAS CREATING PATIENT KNEE INSTABILITY AFTER 13.4 YEARS OF PRODUCT USE BY THE PATIENT. NO INFORMATION WAS REPORTED WITH THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE (B)(4) COMPLAINT AGAINST LOT NUMBER 215691. A TOTAL OF (B)(4) COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER WITH EACH RECORDING INSTABILITY AND PAIN AS THE COMPLAINT CAUSE. INFORMATION WAS NOT PROVIDED THAT DEFINITIVELY IDENTIFIED THE REASON/ROOT CAUSE FOR THE WEAR OTHER THAN NORMAL USE. NO OTHER CONDITIONS RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. THERE IS NO REPORTED INFORMATION THAT INDICATES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THIS PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON REPORTED THAT THE ORIGINAL POLY INSERT WAS WORN DOWN CAUSING THE KNEE TO BE UNSTABLE. HE SWAPPED OUT THE INSERT FROM A 13MM TO A 19MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431895 FOUNDATION KNEE INSERT, ULTRA CON SZ 2 13MM JWH ENCORE MEDICAL, L.P. 215691

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R