BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANTS

    MDR report key: 9245253 · Received October 28, 2019

    Report

    Report Number
    1221934-2019-59270
    Event Type
    Injury
    Date Received
    October 28, 2019
    Report Date
    October 23, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 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: MILLAR, N., ET AL. (2009) "OPEN VERSUS TWO FORMS OF ARTHROSCOPIC ROTATOR CUFF REPAIR", VOL. 467, PAGES 966-978 (AUSTRALIA). THIS STUDY EMPHASIZES ON COMPARING THE CLINICAL AND STRUCTURAL OUTCOMES OF THREE DIFFERENT FORMS OF ROTATOR CUFF REPAIR WITH UP TO 24 MONTHS' FOLLOW-UP. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: THREE COHORTS OF PATIENTS HAD REPAIR OF A SYMPTOMATIC ROTATOR CUFF TEAR USING (1) AN OPEN TECHNIQUE (N = 49); (2) ARTHROSCOPIC KNOTTED (N ¿ 53); OR (3) ARTHROSCOPIC KNOTLESS (N ¿ 57) BY ONE SURGEON. STANDARDIZED PATIENT- AND EXAMINER-DETERMINED OUTCOMES WERE OBTAINED PREOPERATIVELY AND AT 6 WEEKS, 3 AND 6 MONTHS, AND 2 YEARS POSTOPERATIVELY. ULTRASOUND STUDIES WERE PERFORMED WITH A VALIDATED PROTOCOL AT 6 MONTHS AND 2 YEARS POST-SURGERY. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC ROTATOR CUFF REPAIR. THE DEVICES INVOLVED WERE: METALLIC SUTURE ANCHORS (MITEK RC QUICKANCHOR¿; DEPUY MITEK INC, RAYNHAM, MA) (OPEN GROUP, N [6 MONTHS] ¿ 49, N [2 YEARS] = 20), SCREW-IN METALLIC SUTURE ANCHOR (MITEK FASTIN®; DEPUY MITEK INC) (ARTHROSCOPIC KNOTTED GROUP, N [6 MONTHS] = 53, N [2 YEARS] = 29), METALLIC KNOTLESS SUTURE ANCHOR (ARTHROSCOPIC KNOTLESS GROUP, N [6 MONTHS] = 57, N [2 YEARS] = 38). COMPLICATIONS MENTIONED IN THE ARTICLE WERE: ALL OF THESE PATIENTS, EXCEPT ONE IN THE KNOTTED GROUP IN WHICH AN ANCHOR PULLED OUT 5 MONTHS POST-SURGERY, REQUIRED SURGERY AS A RESULT OF TRAUMATIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041847 UNK - IMPLANTS SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention