BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 9167435 · Received October 8, 2019

    Report

    Report Number
    1221934-2019-58846
    Event Type
    Injury
    Date Received
    October 8, 2019
    Report Date
    October 6, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: S.A.R. IBRAHIM ET AL, 2009 ¿ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING AUTOLOGOUS HAMSTRING DOUBLE BUNDLE GRAFT COMPARED WITH SINGLE BUNDLE PROCEDURES¿, THE JOURNAL OF BONE AND JOINT SURGERY (KUWAIT). THE AIM OF THIS STUDY WAS TO EVALUATE THE RESULTS OF DOUBLE BUNDLE ACL RECONSTRUCTION USING AN ANTEROMEDIAL PORTAL AND DOUBLED SEMITENDINOSUS AND DOUBLE GRACILIS TENDON AUTOGRAFTS, WITH TWO TUNNELS ON THE FEMORAL AND THE TIBIAL SIDES. A TOTAL OF 218 PATIENTS WITH UNILATERAL ANTERIOR CRUCIATE LIGAMENT DEFICIENCY WERE RANDOMLY ASSIGNED TO ONE OF FOUR GROUPS. IN GROUP A AN ANATOMICAL DOUBLE BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WAS PERFORMED; GROUP B WERE TREATED BY A SINGLE BUNDLE USING AN ENDOBUTTON FOR FEMORAL FIXATION; IN GROUP C BY A SINGLE BUNDLE USING RIGIDFIX CROSS PINS FOR FEMORAL FIXATION; AND IN GROUP D BY A SINGLE BUNDLE USING A BIOABSORBABLE TRANSFIX II SCREW FOR FEMORAL FIXATION. FOR TIBIAL FIXATION A BIOABSORBABLE INTRAFIX INTERFERENCE SCREW WAS USED FOR ALL THE GROUPS AND THE GRAFT WAS FASHIONED FROM THE SEMITENDINOSUS AND GRACILIS TENDONS IN ALL PATIENTS. IN ALL, 18 PATIENTS WERE LOST TO FOLLOW-UP. THE REMAINING 200 WERE SUBJECTED TO A CLINICAL EVALUATION, WITH ASSESSMENT OF THE ANTERIOR DRAWER, LACHMAN'S AND THE PIVOT-SHIFT TESTS, AND KT-1000 ARTHROMETER MEASUREMENT. THEY ALSO COMPLETED THE INTERNATIONAL KNEE DOCUMENTATION COMMITTEE, LYSHOLM KNEE AND TEGNER ACTIVITY SCORES. THE ARTICLE DESCRIBES THE FOLLOWING SURGICAL PROCEDURES: A DIAGNOSTIC ARTHROSCOPY WAS PERFORMED THROUGH STANDARD ANTEROMEDIAL AND ANTEROLATERAL PORTALS. DOUBLE BUNDLE: GROUP A (N = 50). DOUBLE BUNDLE ACL RECONSTRUCTION WAS UNDERTAKEN USING THE ACUFEX (SMITH &C NEPHEW, ANDOVER, MASSACHUSETTS) DIRECTOR TOOLS FOR ANATOMICAL ACL RECONSTRUCTION." THE METHOD REQUIRES TWO FEMORAL AND TWO TIBIAL TUNNELS WHOSE CENTRES CORRESPONDED TO THE CENTRES OF THE ANATOMICAL ANTEROMEDIAL AND POSTEROLATERAL ATTACHMENTS OF THE ACL. SINGLE BUNDLE: GROUP B (N = 48). THE TIBIAL TUNNEL WAS DRILLED USING THE ACUFEX TIBIAL GUIDE AND A STANDARD CANNULATED DRILL BIT WHICH MATCHED THE DIAMETER OF THE GRAFT. SINGLE BUNDLE: GROUP C (N = 52). THE TIBIAL HOLE WAS MADE IN A STANDARD FASHION USING THE MITEK AIMING GUIDES (JOHNSON &C JOHNSON) WHICH ENABLE TRANSTIBIAL DRILLING OF THE FEMUR AT THE CORRECT POSITION TO A DEPTH OF 30 MM. USING THE MITEK CROSS-PIN GUIDE, TWO CROSS-PIN LOCKING HOLES WERE FASHIONED FROM THE LATERAL ASPECT OF THE FEMUR. SINGLE BUNDLE: GROUP D (N = 50). THE TIBIAL TUNNEL WAS DRILLED IN A STANDARD FASHION AT THE SITE OF ACL FOOTPRINT, CREATING A TUNNEL THAT MATCHED THE DIAMETER OF THE GRAFT. THE DEVICES INVOLVED WERE: RIGIDFIX CROSS-PINS (MITEK), INTRAFIX INTERFERENCE SCREW (MITEK). AT A MEAN OF 29 MONTHS (25 TO 38) FOLLOW-UP THERE WERE NO SIGNIFICANT DIFFERENCES CONCERNING TIME BETWEEN INJURY AND RANGE OF MOVEMENT AND LYSHOLM KNEE SCORES AMONG THE FOUR GROUPS. HOWEVER, THE DOUBLE BUNDLE METHOD SHOWED SIGNIFICANTLY BETTER RESULTS FOR THE PIVOT-SHIFT TEST (P = 0.002). THE KT 1000 MEASUREMENTS SHOWED A MEAN DIFFERENCE BETWEEN THE RECONSTRUCTED KNEE AND THE PATIENTS' NORMAL KNEE OF 1.4 MM IN THE DOUBLE BUNDLE GROUP AND 2.4 MM IN THE SINGLE BUNDLE GROUP; WHICH WAS STATISTICALLY SIGNIFICANT. THE LACHMAN AND ANTERIOR DRAWER TESTS ALSO SHOWED SUPERIOR RESULTS FOR THE DOUBLE BUNDLE METHOD. THE INTERNATIONAL KNEE DOCUMENTATION COMMITTEE SCALE SHOWED NO SIGNIFICANT DIFFERENCE AMONG THE GROUPS (P < 0.001). COMPLICATIONS MENTIONED IN THE STUDY: IN GROUP A, TWO OF THE EARLIER PROCEDURES HAD MIGRATION OF THE ENDOBUTTONS FROM THE LATERAL FEMORAL CORTEX. THIS CAUSED SOME PAIN ON FLEXION AT 20 TO 22 MONTHS POST-OPERATIVELY AND NECESSITATED THEIR REMOVAL AT 23 MONTHS. TWO PATIENTS IN GROUP A HAD SUPERFICIAL WOUND INFECTIONS, WHICH WERE TREATED CONSERVATIVELY WITH ANTIBIOTICS AND SETTLED. TWO PATIENTS IN GROUP D AND ONE IN GROUP C REINJURED THEIR KNEE AND DISRUPTED THE REPAIR OF THEIR SUTURED MENISCI, WHICH WERE REMOVED ARTHROSCOPICALLY. FROM THE REVIEW OF THE ARTICLE ON CLINICAL EVALUATION THE DOUBLE BUNDLE GROUP SHOWED LESS LAXITY THAN THE SINGLE BUNDLE GROUPS. HOWEVER, REGARDLESS OF THE TECHNIQUE, ALL KNEES WERE IMPROVED BY ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION COMPARED WITH THEIR PRE-OPERATIVE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961027 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention