BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT LS INSERT MED 8MM

    MDR report key: 2943862 · Received February 5, 2013

    Report

    Report Number
    0002249697-2013-00566
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K921640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REVIEW CONCLUDED THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW CONCLUDED THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS. THE REPORT CONCLUDED: THE POSTERIOR LOCKING TABS OF THE TIBIAL BASEPLATE SHOWED SIGNS OF CONTACT WITH THE FEMORAL COMPONENT. IT IS PROBABLE THAT THE MAJOR PART OF THE DAMAGE TO THE POSTERIOR LOCKING TABS MUST HAVE OCCURRED PRIOR TO THE REVISION SURGERY OF 2012 BECAUSE THERE WAS NO POSTERIOR DAMAGE TO THE RETURNED TIBIAL INSERT. THE ARTICULATING SURFACE OF THE FEMORAL COMPONENT SHOWED SIGNS OF SCRATCHES AND GOUGES FROM CONTACT WITH THE POSTERIOR LOCKING TABS OF THE TIBIAL BASEPLATE AND FROM CONTACT WITH THE EMBEDDED METAL FRAGMENT IN THE TIBIAL INSERT. THE POSTERIOR LOCKING TAB OF THE TIBIAL BASEPLATE BROKE IN FATIGUE DUE TO REPETITIVE LOADING BY THE FEMORAL COMPONENT. FINAL FRACTURE OF THE FRAGMENT OF THE LOCKING TAB MAY HAVE OCCURRED PRE OR POST THE REVISION SURGERY OF 2012. THE BROKEN FRAGMENT OF THE POSTERIOR LOCKING TAB ENDED UP BEING EMBEDDED IN THE ARTICULATING SURFACE OF THE TIBIAL INSERT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON ANY OF THE COMPONENTS. MEDICAL RECORDS RECEIVED AND EVALUATION: SEVERE POLY WEAR PRESENT PRIOR TO REVISION IN 2012 WITH FLEXION INSTABILITY LEADING TO METAL-METAL CONTACT BETWEEN FEMORAL COMPONENT AND THE POSTERIOR RIM OF THE BASEPLATE ONCE ENOUGH POLY HAD BEEN WORN OFF. FATIGUE FRACTURE OF THE POSTERIOR LOCKING TAB MOST PROBABLY TOOK PLACE BEFORE THE REVISION PROCEDURE IN 2012 WITH THE BROKEN PIECE SHIELDED FROM VIEW BOTH DURING REVISION SURGERY AND ON X-RAY DUE TO THE METAL SHIELDING OF THE LARGE COMPONENTS AROUND. AS SUCH, ROOT CAUSE OF FAILURE IN THIS PI CASE IS PROCEDURE-RELATED AND NOT DEVICE-RELATED WITH NO FURTHER PATIENT-RELATED FACTORS EVIDENT. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE METAL FRAGMENT FOUND EMBEDDED IN THE BEARING SURFACE OF THE TIBIAL INSERT WAS CAUSED BY THE NON-DETECTION OF THE DAMAGE TO THE POSTERIOR ASPECT OF THE BASEPLATE DURING THE PREVIOUS REVISION SURGERY IN (B)(6) 2012. AS SUCH THE ROOT CAUSE IS DETERMINED TO BE USER RELATED IN THAT THE DAMAGE TO THE POSTERIOR ASPECT OF THE BASEPLATE WAS NOT DETECTED SOONER. THE EVENT IS NOT DEVICE-RELATED.

    Description of Event or Problem · 1

    PATIENT PRESENT TO SURGEONS OFFICE WITH SWOLLEN KNEE POST REPLACEMENT OF INSERTS TO FIND A PIECE OF METAL SHOWING ON XRAY. SURGERY TO EXPLORE WAS SET.

    Description of Event or Problem · 1

    PATIENT PRESENT TO SURGEONS OFFICE WITH SWOLLEN KNEE POST REPLACEMENT OF INSERTS TO FIND A PIECE OF METAL SHOWING ON XRAY. SURGERY TO EXPLORE WAS SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48584 KX+ DURAT LS INSERT MED 8MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBG927

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention