BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - IMPLANTS

    MDR report key: 9150358 · Received October 3, 2019

    Report

    Report Number
    1221934-2019-58783
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Report Date
    October 2, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. UNKNOWN ANCHORS AND SCREWS. 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 IS REPORT 2 OF 2 FOR THE SAME EVENT. THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ANTONOGIANNAKIS, E. ET AL, ¿ARTHROSCOPIC TREATMENT OF THE ACUTE AND CHRONIC ANTERIOR INSTABILITY OF THE SHOULDER- EARLY RESULTS¿, PAGES 1-8, GREECE. THE GOALS OF THE SURGICAL RECONSTRUCTION OF THE ANTERIOR SHOULDER INSTABILITY ARE (A) REATTACHMENT OF THE LABRUM, (B) RESTORATION OF THE CAPSULAR TENSION, (C) IMPROVEMENT OF THE RANGE OF MOTION, (D) EARLY REHABILITATION, MUSCULAR STRENGTHENING AND PROPRIOCEPTIVE TRAINING. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: BETWEEN SEPTEMBER 1999 AND AUGUST 2000 42 PATIENTS WITH ACUTE AND CHRONIC SHOULDER INSTABILITY UNDERWENT SURGICAL STABILIZATION. THE NUMBER OF DISLOCATIONS OR SUBLUXATIONS RANGED BETWEEN 1 AND 20 (MEAN 8.7). THIRTY-TWO PATIENTS UNDERWENT ARTHROSCOPIC AND THE REST OF THEM OPEN RECONSTRUCTION DUE TO TECHNICAL DIFFICULTIES OR DUE TO THE BAD CONDITION OF THE CAPSULOLIGAMENTOUS TISSUES. ALL PATIENTS WERE CLINICALLY EXAMINED PREOPERATIVELY UNDER ANESTHESIA [HAWKINS AND BOKOR 1990]. THE PREOPERATIVE EVALUATION INCLUDED THE PERFORMANCE OF PLAIN X-RAYS AND IN CERTAIN PATIENTS MRI. THE PATIENTS SELECTED FOR ARTHROSCOPIC STABILIZATION HAD (1) TRAUMATIC, ANTERIOR INSTABILITY, (2) BANKART LESION, (3) ROBUST, WELL DEVELOPED INFERIOR GLENOHUMERAL LIGAMENT, (4) ABSENCE OF ANTERIOR GLENOID RIM EROSION, (5) NO PEAR-SHAPED GLENOID AND (6) NON-ENGAGING HILL-SACHS LESION. THE ARTHROSCOPIC PROCEDURE HAS BEEN ABANDONED IN A FEW PATIENTS DUE TO TECHNICAL REASONS OR DUE TO INAPPROPRIATE CONDITION OF THE GLENOHUMERAL LIGAMENTS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: THE SURGICAL TECHNIQUE HAD AS FOLLOWS: THE INSERTION OF THE ARTHROSCOPE FROM THE POSTERIOR PORTAL WAS FOLLOWED BY OPENING OF THE ANTEROSUPERIOR AND THE ANTEROINFERIOR PORTALS, USING THE OUT-IN TECHNIQUE, IN ORDER TO MAXIMIZE THE WIDTH OF THE SKIN BRIDGE BETWEEN THE ANTERIOR PORTALS AND TO FACILITATE THE INSERTION OF ARTHROSCOPIC INSTRUMENTS. AFTER IDENTIFICATION OF THE INTRAARTICULAR PATHOLOGY THE LABRUM IS DETACHED FROM THE INFERIOR PART OF THE CAPSULE TO THE 6 HOURS. THE GLENOID NECK IS DEBRIDED IN ORDER TO FACILITATE SOFT TISSUE REATTACHMENT. THE HOLES FOR THE INSERTION OF THE BONE ANCHORS ARE MADE ON THE ARTICULAR SURFACE OF THE GLENOID, 4 MM FROM ITS EDGE (FIGURE 2). THE ANCHORS ARE INSERTED IN THE 7, 9 AND 10 HOURS IN THE LEFT GLENOID AND IN THE 2, 4, 5 HOURS IN THE RIGHT GLENOID (FIGURE 3). THERE HAVE BEEN INSERTED 84 ANCHORS OF SEVERAL TYPES. WE HAVE USED ELEVEN NON ABSORBABLE, SCREW TYPE ANCHORS, 6 METALLIC KNOTLESS ANCHORS (MITEK), 33 FASTAK ANCHORS (ARTHREX) AND 34 ABSORBABLE PANALOK ANCHORS (MITEK). THE ANGLE OF ANCHOR INSERTION MUST BE AS PERPENDICULAR TO THE GLENOID AS POSSIBLE AND NOT PARALLEL TO IT, TO AVOID INTRAARTICULAR PROMINENCE OR DISLODGMENT. AFTER INSERTION OF THE ANCHOR TRACTION IS EXERTED THROUGH THE ANCHORS AND THEIR STABILITY IS ASSURED. THE UNHINDERED GLIDING OF THE ANCHORS IS ALSO EXAMINED AT THAT POINT. THE FIXATION STRENGTH MAY BE AUGMENTED IN SEVERAL POSITIONS: (A) IN THE LABRUM-CAPSULE INTERFACE, (B) IN THE ROTATOR INTERVAL AND (C) USING THE METHOD OF CAPSULAR SHRINKAGE. THIS TECHNIQUE RELIES OF HEATING OF THE CAPSULAR COLLAGEN AT 65° C USING RADIOFREQUENCY DEVICES WHICH LEADS TO ALTERATION OF THE LINKS BETWEEN THE COLLAGEN FIBERS AND TO THE CREATION OF A VISIBLE SCAR. DURING THE OPERATION, THE ANATOMIC VARIATIONS MUST BE CONSIDERED, HAVING IN MIND THAT IS ESSENTIAL TO ENSURE THAT THE CAPSULAR TENSION IS SYMMETRICAL, BECAUSE UNBALANCED TENSION MAY LEAD TO SUBLUXATION IN THE OPPOSITE DIRECTION. AFTER COMPLETION OF THE OPERATION THE JOINT WAS THOROUGHLY WASHED, 25 ML XYLOCAINE WERE INSTILLED INTRAARTICULARLY AND THE PORTALS HAVE BEEN ALSO INFILTRATED TO ENSURE POSTOPERATIVE ANALGESIA. ALL PATIENTS RECOVERED FROM ANESTHESIA UNEVENTFULLY. THE POSTOPERATIVE PAIN WAS MEASURED USING A 100-MM VISUAL ANALOGUE SCALE. POST-OPERATIVELY NSAIDS HAVE BEEN ADMINISTERED INTRAMUSCULARLY. THE POSITION OF THE BONE ANCHORS HAS BEEN VERIFIED IN THE POSTOPERATIVE ANTEROPOSTERIOR SHOULDER RADIOGRAPH. THE DEVICES INVOLVED WERE: ELEVEN NON ABSORBABLE, SCREW TYPE ANCHORS, 6 METALLIC KNOTLESS ANCHORS, AND 34 ABSORBABLE PANALOK ANCHORS. COMPLICATIONS MENTIONED IN THE CASE REPORT WERE: ALL PATIENTS, EXCEPT ONE, WHO WAS LOST TO FOLLOW UP, HAVE BEEN FOLLOWED UP POSTOPERATIVELY FOR 4-15 MONTHS (MEAN 9 MONTHS). IN ALL PATIENTS THE APPREHENSION HAS BEEN DISAPPEARED. UNTIL THE END OF DECEMBER 2000 NO RECURRENCE OCCURRED. SEVEN PATIENTS REPORTED MILD PAIN AFTER INTENSE ACTIVITY. ONE PATIENT DEVELOPED SHOULDER PAIN, 5 MONTHS POSTOPERATIVELY, DUE TO IMPINGEMENT AND WAS TREATED CONSERVATIVELY WITH SUCCESS, BY PHYSIOTHERAPY PROGRAM CHANGE. THREE TO FIVE ANCHORS PER PATIENT HAVE BEEN USED. SUTURE BREAKAGE OCCURRED ONLY IN THE FIRST CASES. NO INFECTION OR NEURAPRAXIA WAS NOTED. STIFFNESS LASTING MORE THAN 4 MONTHS WAS NOTED IN 3 PATIENTS AND WAS TREATED WITH INTENSIFICATION OF THE PHYSIOTHERAPY PROGRAM. ALL PATIENTS HAD FORWARD FLEXION 180° AND INTERNAL ROTATION TO THE LEVEL OF T6 (T4-T12), LIKE THE NORMAL SHOULDER. THE FUNCTIONAL RESULT WAS EVALUATED WITH THE ROWE AND ZARINS SCALE (TABLE 1). EXCELLENT WAS RATED THE RESULT OF THE SURGICAL RECONSTRUCTION, WHEN THE PATIENT HAD GOOD FUNCTION, WITHOUT SIGNIFICANT COMPLAINTS. TWENTY-FIVE PATIENTS HAD EXCELLENT RESULT (SCORE 90-100), FIVE GOOD RESULT (SCORE 70-89) AND TWO SATISFACTORY RESULT (SCORE 40-69).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944555 UNK - IMPLANTS SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1