BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 3757054 · Received April 17, 2014

    Report

    Report Number
    1644408-2014-00228
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K932425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL KEPT FOR PROCESSING.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS POOR FIXATION AFTER 4 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR REVISION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE HOSPITAL KEPT THE DEVICE FOR PROCESSING; IT WAS NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED 1 NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THIS PRODUCT. NCMR 12536 SHOWED 1 PART (PART NUMBER: 324-01-106) THAT HAD A NON-CONFORMANCE OF "PIT AND BUMPS". THE PART WAS ACCEPTED WITH THE JUSTIFICATION "PIT AND BUMPS IN CASTED STEM AREA - SURFACE IS BEAD BLASTED." A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR THIS LOT. THE ROOT CAUSE FOR THE DEVICES POOR FIXATION COULD NOT BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE TIBIA SUBSIDING AND CAUSING PAIN. THIS IS NOT A PRODUCT ISSUE. THE SURGEON FOUND THE PRODUCT IN PRISTINE CONDITION, THE TIBIA HAD SEPARATED FROM THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234542 FOUNDATION KNEE FOUNDATION NON-POROUS STEMMED TIBIA 6 RIGHT JWH ENCORE MEDICAL, L.P. 54057445

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 380-09-506,LOT 54009882