BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GRYPHON

    MDR report key: 9146054 · Received October 2, 2019

    Report

    Report Number
    1221934-2019-58763
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    May 11, 2017
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BONNEVIALLE, N., ET AL (2017), RESULTS OF ARTHROSCOPIC BANKART REPAIR WITH HILL-SACHS REMPLISSAGE FOR ANTERIOR SHOULDER INSTABILITY, INTERNATIONAL ORTHOPAEDICS, VOL.41, PAGES 2573-2580 (FRANCE). DOI: 10.1007/S00264-017-3491-5. THE STUDY EMPHASIZES ON EVALUATING MID-TERM OUTCOME OF BANKART REPAIR WITH HILL-SACHS REMPLISSAGE (BHSR) AND HIGHLIGHTING PROGNOSTIC FACTORS OF FAILURE. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: A TOTAL OF 34 PATIENTS (30 MALES AND 4 FEMALES) OPERATED ON FOR ANTERIOR SHOULDER INSTABILITY WITH BHSR FROM NOVEMBER 2009 TO JANUARY 2014, WITH A MEAN AGE AT TIME OF SURGERY OF 26 YEARS (RANGE, 15-49; ± 8.5). INCLUSION CRITERIA WERE: PATIENT OPERATED ON FOR TRAUMATIC ANTERIOR SHOULDER INSTABILITY WITH AN INSTABILITY SEVERITY INDEX SCORE (ISIS) ABOVE 3 POINTS; NO SUBSTANTIAL GLENOID BONE LOSS; TREATED WITH AN ARTHROSCOPIC BANKART REPAIR ASSOCIATED WITH A HILL-SACHS REMPLISSAGE; AND FOLLOWED FOR A MINIMUM OF 24 MONTHS. POSTOPERATIVELY, THE ARM WAS PLACED IN A SLING IN INTERNAL ROTATION FOR 6 WEEKS WITH NO EXTERNAL ROTATION ABOVE THE NEUTRAL POSITION DURING THE PERIOD. SELF-PENDULUM EXERCISES WERE REQUIRED IMMEDIATELY AFTER THE SURGERY AND FORMAL PHYSIOTHERAPY WAS DELAYED AT 3 WEEKS. SPORTS ACTIVITIES WITHOUT RISK FOR THE SHOULDER WERE ALLOWED AT 3 MONTHS, AND OVERHEAD OR CONTACT SPORTS AT 6 MONTHS POSTOPERATIVELY. X-RAYS WERE PERFORMED AT EACH REVIEW AND ALLOWED TO FOLLOW RADIOGRAPHIC EVOLUTION OF ABSORBABLE ANCHORS USED FOR THE BANKART REPAIR AND THE HILL-SACHS REMPLISSAGE. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC BANKART REPAIR WITH A HILL-SACHS REMPLISSAGE. THREE DIFFERENT PORTALS WERE USED FOR THE ARTHROSCOPIC BHSR PROCEDURE: A STANDARD POSTERIOR PORTAL AND ANTEROSUPERIOR PORTALS FOR THE BANKART REPAIR AND CAPSULAR SHIFT, AND AN ACCESSORY POSTEROLATERAL OUT-IN PORTAL FOR THE REMPLISSAGE OF THE HUMERAL BONE DEFECT. THE DEVICES INVOLVED WERE: 2 ABSORBABLE ANCHORS (GRYPHON BR; DEPUY MITEK; RAYNHAM, MA, USA) WERE USED ALONG WITH A 6.5-MM CANNULA, A DRILL GUIDE, AND A PENETRATING GRASPER. COMPLICATIONS MENTIONED IN THE ARTICLE: 5 PATIENTS HAD A RECURRENCE OF INSTABILITY. 3 PATIENTS HAD A PERSISTENT ANTERIOR APPREHENSION OR PAIN IN ABDUCTION EXTERNAL ROTATION. 1 PATIENT DESCRIBED A PERSISTENT POSTERIOR SHOULDER PAIN IN ABDUCTION BEYOND 6 MONTHS AFTER SURGERY. THREE-FIFTHS OF THE UNSTABLE PATIENTS AFTER THE PRIMARY SURGERY REQUIRED A REVISION WITH AN OPEN LATARJET PROCEDURE WITHOUT COMPLICATION. ON RADIOGRAPHIC ANALYSIS, 2 PATIENTS HAD SIGNS OF OSTEOARTHRITIS. FROM THE REVIEW OF THE ARTICLE, IT IS CONCLUDED THAT THE BHSR IS A SAFE PROCEDURE TO ADDRESS ANTERIOR SHOULDER INSTABILITY. HOWEVER, THE DEPTH OF THE HILL-SACHS OF MORE THAN 20% OF THE HUMERAL HEAD WOULD BE A LIMIT TO INDICATE A BHSR, AND AN ALTERNATIVE SURGERY SHOULD BE CONSIDERED IN THIS PREOPERATIVE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939666 UNKNOWN GRYPHON SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention