BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN RIGIDFIX CROSS PIN

    MDR report key: 9186577 · Received October 14, 2019

    Report

    Report Number
    1221934-2019-58934
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Report Date
    October 9, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NOH, JH., ET AL (2017), ONE-YEAR SERIAL FOLLOW-UP MAGNETIC RESONANCE IMAGING STUDY OF RIGIDFIX FOR FEMORAL FIXATION IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, KNEE SURGERY AND RELATED RESEARCH, VOL.29(3), PAGES 203-209 (SOUTH KOREA). THE STUDY EMPHASIZES ON ASSESSING GRAFT SLIPPAGE AT THE SITE OF FEMORAL FIXATION BY FOLLOW-UP MAGNETIC RESONANCE IMAGING (MRI) AFTER ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH A FOUR-STRAND AUTOGENOUS HAMSTRING TENDON USING RIGIDFIX FOR AT LEAST ONE YEAR. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: TWENTY-TWO SUBJECTS WHO UNDERWENT ACL RECONSTRUCTION USING AN AUTOGENOUS HAMSTRING TENDON BETWEEN (B)(6) 2008 AND (B)(6) 2011 WERE INCLUDED IN THE STUDY. RUPTURE OF THE ACL WAS DIAGNOSED BY PHYSICAL EXAMINATION AND CONFIRMED BY ARTHROSCOPY. THE INCLUSION CRITERIA WERE THOSE WHO UNDERWENT PRIMARY ACL RECONSTRUCTION USING RIGIDFIX FOR FEMORAL FIXATION. PATIENTS WHO HAD A CONCURRENT MEDIAL COLLATERAL LIGAMENT (MCL) INJURY THAT WAS MANAGED WITH CONSERVATIVE TREATMENT OR A CONCURRENT MENISCUS TEAR THAT WAS MANAGED WITH PARTIAL MENISCECTOMY. 21 SUBJECTS WERE FOLLOWED UP FOR AT LEAST ONE YEAR. PRIOR TO THE INITIATION OF CONTINUOUS PASSIVE MOTION (CPM) EXERCISES, POSTOPERATIVE MRI WAS PERFORMED. CPM EXERCISES FROM 0° TO 50° BEGAN ON THE FOURTH POSTOPERATIVE DAY AND ADVANCED TO 90° IN THE SECOND POSTOPERATIVE WEEK AS TOLERATED. PARTIAL WEIGHT BEARING WAS ALLOWED ON THE FOURTH POSTOPERATIVE DAY AND TOTAL WEIGHT BEARING AS TOLERATED WAS PERMITTED. DURING AMBULATION, THE SUBJECTS WORE A KNEE BRACE LOCKED IN EXTENSION FOR A FEW WEEKS UNTIL QUADRICEPS BECAME STRONGER. AFTER 12 WEEKS, JOGGING AND STATIONARY BICYCLING WERE ALLOWED. AFTER 6 MONTHS, EACH SUBJECT WAS ALLOWED TO PARTICIPATE IN COMPETITIVE SPORTS OF ONE¿S CHOICE, EXCEPT FOR THOSE EXERCISES THAT MIGHT INVOLVE STRONG CONTACT WITH OTHERS OR THOSE EXERCISES THAT MIGHT IMPOSE STRONG EXTERNAL FORCES ON THE SUBJECT. ALL KINDS OF EXERCISES WERE ALLOWED AFTER 9 MONTHS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: AN ACL RECONSTRUCTION USING AN AUTOGENOUS HAMSTRING TENDON. THE DEVICES INVOLVED WERE: RIGIDFIX (DEPUY MITEK), TIBIAL INTRAFIX (DEPUY MITEK) AND NO. 2 ETHIBOND. COMPLICATION MENTIONED IN THE ARTICLE: 1 CASE HAD A FLEXION DEFICIT OF 5° COMPARED TO THE OTHER KNEE. 1 CASE SHOWED BREAKAGE OF THE LOWER CROSS-PIN ON POSTOPERATIVE MRI. 1 CASE SHOWED BREAKAGE OF THE UPPER CROSS-PIN ON MRI AT 6 MONTHS AFTER SURGERY. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978387 UNKNOWN RIGIDFIX CROSS PIN SOFT-TISSUE ANCHOR, BIOABSORBABLE HTY DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention