BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GII ANCHOR

    MDR report key: 9244212 · Received October 28, 2019

    Report

    Report Number
    1221934-2019-59248
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    April 27, 2005
    Report Date
    October 23, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 PRODUCT: 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 SURVEYS 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: LAI, D., ET AL (2006), OPEN BANKART REPAIR WITH SUTURE ANCHORS FOR TRAUMATIC RECURRENT ANTERIOR SHOULDER INSTABILITY: COMPARISON OF RESULTS BETWEEN SMALL AND LARGE BANKART LESIONS, KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY, VOL. 14, PAGES 82-87 (TAIWAN). DOI: 10.1007/S00167-004-0615-4. THE STUDY EMPHASIZES ON DEMONSTRATING THE CLINICAL OUTCOME OF OPEN BANKART RECONSTRUCTION WITH THE AID OF SUTURE ANCHOR AND CAPSULAR SHIFT PROCEDURE AND EVALUATING WHETHER THE SIZE OF BANKART LESIONS (<3 CLOCK UNITS VS >3 CLOCK UNITS) COULD AFFECT SURGICAL RESULTS OF TRAUMATIC ANTERIOR INSTABILITY OF THE SHOULDER. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: FROM 1992 TO 2000, 82 PATIENTS (66 MALE AND 16 FEMALE) WITH SURGERY-CONFIRMED TRAUMATIC RECURRENT ANTERIOR-INFERIOR GLENOHUMERAL INSTABILITY WITH BANKART LESION WERE INCLUDED IN THE STUDY (40 GOT THEIR FIRST DISLOCATION DURING CONTACT SPORTS, 25 DURING MANUAL LABORS, AND 17 IN A TRAUMATIC FALL). THERE WERE 61 RIGHT (74%) AND 21 LEFT (26%) SHOULDERS INVOLVED. MEAN AGES AT OPERATION WERE 27.3 ± 9.1 YEARS OLD. THE PATIENTS WERE CATEGORIZED INTO 2 GROUPS BASED ON THE SIZE OF BANKART LESION: SMALL LESION (BANKART LESIONS WITH <3 CLOCK UNITS) AND LARGE LESION (BANKART LESIONS WITH >3 CLOCK UNITS). THERE WERE 8 PATIENTS WITH 1-2 UNITS OF CLOCK, 21 PATIENTS WITH 2-3 UNITS OF CLOCK, 24 PATIENTS WITH 3-4 UNITS OF CLOCK, AND 29 PATIENTS WITH >4 UNITS OF CLOCK OF BANKART LESIONS. AFTER THE OPERATION, THE ARM WAS PLACED IN A SLING AND SWATHE. PASSIVE FORWARD FLEXION WAS PERFORMED 2 WEEKS AFTER THE OPERATION, AND GENTLE EXTERNAL ROTATION WITHOUT EXCEEDING NEUTRAL POSITION WAS PERFORMED 4 WEEKS AFTER THE OPERATION. SIX WEEKS AFTER THE OPERATION, ALL THE PATIENTS WERE ENCOURAGED TO INCREASE AGGRESSIVE STRENGTHENING AND MOBILIZATION INTO EXTERNAL ROTATION. PATIENTS WERE EXPECTED TO REGAIN 80% OF NORMAL RANGE OF MOTION AT 3 MONTHS AFTER THE OPERATION. NON-CONTACT SPORTS WERE ALLOWED AT 4 MONTHS AND CONTACT SPORTS WERE PERMITTED 6 MONTHS AFTER THE OPERATION FOR PATIENTS WHO HAD REGAINED RANGE OF MOTION AND MUSCLE STRENGTH. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: AN OPEN BANKART REPAIR WITH SUTURE ANCHORS AND CAPSULAR SHIFT PROCEDURE FOR TRAUMATIC RECURRENT ANTERIOR SHOULDER INSTABILITY. THE DEVICE INVOLVED WAS: SUTURE ANCHOR (MITEK SURGICAL PRODUCTS, (B)(4), USA). COMPLICATIONS MENTIONED IN THE ARTICLE: 6 PATIENTS EXPERIENCED POSTOPERATIVE APPREHENSION DURING SPORT ACTIVITIES. 1 PATIENT HAD DISLOCATION AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040151 UNKNOWN GII ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention