BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANTS

    MDR report key: 9244357 · Received October 28, 2019

    Report

    Report Number
    1221934-2019-59254
    Event Type
    Injury
    Date Received
    October 28, 2019
    Report Date
    October 23, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 IMPLANTS. 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 IS REPORT 1 OF 2 FOR THE SAME EVENT. THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: J.R. WALTON, ET AL, 2012 ¿A TWO-YEAR CLINICAL OUTCOMES STUDY OF 400 PATIENTS, COMPARING OPEN SURGERY AND ARTHROSCOPY FOR ROTATOR CUFF REPAIR¿, BONE AND JOINT RESEARCH VOL.1, NO.9, PAGES 210-217 (AUSTRALIA). THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER THERE IS ANY SIGNIFICANT DIFFERENCE IN TEMPORAL MEASUREMENTS OF PAIN, FUNCTION AND RATES OF RE-TEAR FOR ARTHROSCOPIC ROTATOR CUFF REPAIR (RCR) PATIENTS COMPARED WITH THOSE PATIENTS UNDERGOING OPEN RCR. THIS STUDY WAS BASED ON PROSPECTIVELY COLLECTED DATA FROM TWO NON-RANDOMISED COHORTS OF CONSECUTIVE PATIENTS WITH SYMPTOMATIC ROTATOR CUFF TEARS WHO UNDERWENT EITHER OPEN RCR (N = 200) OR ARTHROSCOPIC RCR (N = 200) AND WHO SATISFIED THE ELIGIBILITY REQUIREMENTS. ETHICAL APPROVAL FOR THIS STUDY WAS GIVEN BY THE SOUTH EAST HEALTH HUMAN RESEARCH ETHICS COMMITTEE ((B)(6)). THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: FOR OPEN RCR, THE DELTOID IS SPLIT IN LINE WITH ITS FIBRES. THE CORACOACROMIAL LIGAMENT IS DETACHED AND SUBSEQUENTLY REATTACHED TO THE ANTERIOR ACROMION. THE GREATER TUBEROSITY IS VISUALISED AND GENTLY ROUGHENED WITH A RASP, AND THE EDGES OF THE TORN TENDON DEBRIDED PRIOR TO REPAIR. ANTERIOR ACROMIOPLASTY AND BURSECTOMY ARE PERFORMED ALONG WITH APPROPRIATE SOFT-TISSUE RELEASES (SUBACROMIAL AND EXTRA-ARTICULAR ADHESIONS, CORACOHUMERAL LIGAMENT AND ROTATOR CUFF INTERVAL). METALLIC SUTURE ANCHORS (QUICKANCHOR; DEPUY, (B)(4)) ARE TAPPED DIRECTLY INTO THE PROXIMAL HUMERUS WITHOUT PRE-DRILLING. SUTURE ANCHORS ARE PLACED IN THE ROTATOR CUFF FOOTPRINT AND SUTURES ARE PASSED THROUGH THE TENDON EDGES: THE TENDONS ARE REPAIRED USING A HORIZONTAL MATTRESS STITCH CONFIGURATION. A TWO-ROW ANCHOR TECHNIQUE WAS USED FOR FIXATION WHEN SUFFICIENT EXCURSION OF THE TORN TENDON WAS AVAILABLE. FOR ARTHROSCOPIC RCR, THE THREE-PORTAL TECHNIQUE IS USED. THE EDGE OF THE ROTATOR CUFF TEAR AND THE LANDING SITE AT THE GREATER TUBEROSITY ARE GENTLY DEBRIDED, SMOOTHING THE TUBEROSITY WITH AN ARTHROSCOPIC BURR. ACROMIOPLASTY WAS PERFORMED IN 73% OF THE ARTHROSCOPIC PATIENTS (N = 146). THE REPAIR WAS UNDERTAKEN USING A SINGLE-ROW TECHNIQUE.' DOUBLE SUTURE-LOADED 5 MM METAL CORKSCREW ANCHORS (MITEK FASTIN; DEPUY) WERE INSERTED THROUGH THE LATERAL ACCESSORY PORTAL, ANTERIORLY TO POSTERIORLY IN A SINGLE ROW IN THE ROTATOR CUFF FOOTPRINT IN 58 PATIENTS (29%) OF THE ARTHROSCOPIC GROUP. AFTER AUGUST 2005, OPUS METALLIC KNOTLESS SUTURE ANCHORS (ARTHROCASE, (B)(4)) WERE USED IN A SINGLE INVERTED MATTRESS (TENSION BAND) CONFIGURATION, ACCOUNTING FOR THE REMAINING 142 PATIENTS (71%). THE DEVICES INVOLVED WERE: METALLIC SUTURE ANCHORS (QUICKANCHOR; DEPUY, (B)(4)), DOUBLE SUTURE-LOADED 5 MM METAL CORKSCREW ANCHORS (MITEK FASTIN; DEPUY). COMPLICATIONS MENTIONED IN THE STUDY: THE OPEN RCR GROUP HAD 13 PATIENTS WHO ALSO PRESENTED WITH ADHESIVE CAPSULITIS, 15 WITH MILD OSTEOARTHRITIS, THREE WITH SUPERIOR LABRAL TEAR FROM ANTERIOR TO POSTERIOR (SLAP) LESIONS AND TWO WITH CALCIFIC TENDINOSIS. IN THE ARTHROSCOPIC GROUP, NINE PATIENTS HAD ADHESIVE CAPSULITIS, 12 HAD MILD OSTEOARTHRITIS AND THREE HAD CALCIFIC TENDINOSIS. APPROXIMATELY 150 PATIENTS (75%) OF THE OPEN RCR GROUP AND 174 (87%) OF THE ARTHROSCOPIC RCR GROUP EXHIBITED IMPINGEMENT PREOPERATIVELY, IN EITHER OR BOTH DIRECTIONS (P = 0.003). THESE PROPORTIONS DECREASED TO 46 (23%) FOR BOTH THE OPEN RCR PATIENTS AND THE ARTHROSCOPIC RCR PATIENTS AT TWO YEARS (P = 0.905). A TOTAL OF 14 PATIENTS (7%) IN THE OPEN GROUP UNDERWENT REVISION SURGERY FOR RE-TEAR, COMPARED WITH EIGHT PATIENTS (4%) IN THE ARTHROSCOPY GROUP. FROM THE REVIEW OF THE ARTICLE IT CAN BE CONCLUDED THAT ARTHROSCOPIC RCR INVOLVED LESS EXTREME PAIN THAN OPEN RCR, EARLIER FUNCTIONAL RECOVERY, A SHORTER OPERATIVE TIME AND BETTER REPAIR INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039605 UNK - IMPLANTS SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention