BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2717749 · Received August 23, 2012

    Report

    Report Number
    1644408-2012-00451
    Event Type
    Other
    Date Received
    August 23, 2012
    Date of Event
    July 4, 2012
    Report Date
    July 4, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 AN AGENT INFORMED DJO SURGICAL THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2012 INVOLVING A BROKEN MODULAR TIBIAL STEM. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012, GIVING THE EXPLANTED DEVICE A TIME IN-VIVO OF LESS THAN THREE MONTHS. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED. THERE WAS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE TIBIAL STEM FRACTURE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REVISION TIBIAL BASEPLATE AND MODULAR TIBIAL STEM SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE SECOND COMPLAINT FOR THIS PART NUMBER DUE TO HANDLING DAMAGE TO THE STERILE PACKAGING. A VISUAL EXAMINATION OF THE EXPLANTED DEVICES INDICATES THAT THE ROOT CAUSE OF THE STEM FRACTURE WAS MOST LIKELY CAUSED BY BENDING FATIGUE AS A SECONDARY EFFECT FROM CEMENT MANTEL LOOSENING AND TIBIAL PLATEAU COLLAPSE. KNOWN CAUSES OF TIBIAL COMPONENT LOOSENING INCLUDE: TILT IN A MEDIAL/LATERAL DIRECTION, CHANGE IN THE ALIGNMENT OF THE EXTREMITY, CRACK FORMATION AT CEMENT-IMPLANT INTERFACE, THIRD-BODY WEAR, COMPROMISED PROXIMAL TIBIAL BONE QUALITY, TRAUMA, IMPROPER STRESS LOADS, POOR CEMENTING TECHNIQUES, AND HIGH ROTATIONAL CONSTRAINT. X-RAY IMAGES PROVIDED POST OPERATIVE OF THE PRIMARY SURGERY SUGGEST INSUFFICIENT BONY PURCHASE TO SUPPORT THE TIBIAL BASEPLATE WITH LUCENCY BETWEEN THE LATERAL AUGMENTATION BLOCK AND PROXIMAL TIBIAL BONE.

    Description of Event or Problem · 1

    REVISION SURGERY- THE TIBIAL MODULAR STEM WAS BROKEN IN TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE TIBIAL REVISION STEM JWH ENCORE MEDICAL, L.P. 157B1002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 322-01-104, LOT 190B1004| 321-10-104, LOT 182B1004| 322-05-104, LOT 199B1003| 206-01-006, LOT 757A1016| 220-10-016, LOT 862A1003