BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEEALIGN TIBIAL JIG

    MDR report key: 1910655 · Received November 22, 2010

    Report

    Report Number
    3007521480-2010-00001
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ORTHALIGN INC.
    Product Code
    OLO
    PMA / PMN Number
    K093998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (REVIEW OF POST-OPERATIVE X-RAYS FROM THE CASE). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A REVIEW OF THE COMPLAINT DATABASE CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS OF THIS ISSUE. REVIEW OF DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. INTERNAL INVESTIGATION BASED ON THE INFO RECEIVED COULD NOT DETERMINE IF AND THE EXTENT TO WHICH THE KNEEALIGN TIBIAL JIG CONTRIBUTED TO INTRA-OPERATIVE TIBIAL FRACTURE. ALL AVAILABLE INFO (INCLUDING RISK ANALYSIS AND HEALTH HAZARD EVAL) HAVE BEEN PLACED ON FILE IN QUALITY MGMT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. SHOULD ANY ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING TOTAL KNEE ARTHROPLASTY (LEFT LEG) PT OBTAINED AN INTRA-OPERATIVE TIBIAL FRACTURE THAT EXTENDED FROM THE RESECTION PLANE TO THE MEDIAL 1/3 OF THE TUBERCLE. THE SPLIT EXTENDED APPROX 1 INCH FROM THE RESECTION PLANE DISTALLY AND APPROX 1/2 INCH POSTERIORLY AT THE RESECTION PLANE. SURGEON WAS ABLE TO MAKE TIBIA RESECTION USING THE KNEEALIGN SYSTEM SUCCESSFULLY. KNEEALIGN TIBIAL JIG WAS REMOVED FROM THE PT, DURING PREPARATION WITH ZIMMER NEXGEN TIBIAL FIN PUNCH (BROACH), THE TIBIA WAS FRACTURED. SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNEEALIGN TIBIAL JIG EXTRAMEDUALLARY TIBIAL RESECTION JIG OLO ORTHALIGN INC. 401321

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention