BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANTS

    MDR report key: 9214361 · Received October 21, 2019

    Report

    Report Number
    1221934-2019-58896
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    December 4, 2013
    Report Date
    October 7, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: GOTO, M., ET AL (2015), RAPID COLLAPSE OF THE HUMERAL HEAD AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR, KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY, VOL.23(2), PAGES 514-516 (JAPAN). DOI: 10.1007/S00167-013-2790-7. THE STUDY EMPHASIZES ON A 69-YEAR-OLD WOMAN WITH NO PARTICULAR REMARKABLE MEDICAL HISTORY OR RISK FACTORS FOR OSTEONECROSIS. THE PATIENT HAD BRUISED HER RIGHT SHOULDER IN A FALL AND UNDERGONE CONSERVATIVE THERAPY WITHOUT STEROID ADMINISTRATION FOR 18 MONTHS. THE PATIENT WAS REFERRED TO A HOSPITAL BECAUSE OF PERSISTENT SHOULDER PAIN. SHE COMPLAINED OF NOCTURNAL PAIN, ALTHOUGH NO HEAT OR SWELLING WAS DETECTED. ACTIVE AND PASSIVE RANGES OF MOTION OF THE RIGHT SHOULDER WERE BOTH MARKEDLY LIMITED. MAGNETIC RESONANCE IMAGING SHOWED A MASSIVE TEAR OF THE ROTATOR CUFF FROM THE SUBSCAPULARIS TENDON TO THE INFRASPINATUS TENDON, AND WITH ARTHROSCOPY, WITH A COMPLETE TEAR OF THE TENDON OF THE LONG HEAD OF THE BICEPS WAS OBSERVED. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: AN ARTHROSCOPIC ROTATOR CUFF REPAIR, A PARTIAL SINGLE-ROW REPAIR OF BOTH THE INFRASPINATUS AND SUBSCAPULARIS TEARS USING 2 METAL ANCHORS, AND A HUMERAL HEAD REPLACEMENT. THE DEVICES INVOLVED WERE: TWO METAL ANCHORS (FASTIN RC, RAYNHAM, MA) AND CTA HEAD. COMPLICATION MENTIONED IN THE ARTICLE: RECURRENCE OF THE PAIN IN THE RIGHT SHOULDER ACCOMPANIED BY LOCAL HEAT AND SWELLING. COMPUTED TOMOGRAPHY (CT) SCAN SHOWED HUMERAL HEAD COLLAPSE WITH A PARTIAL LESION OF THE GLENOID CAVITY. MAGNETIC RESONANCE IMAGING SHOWED RECURRENT TEARING OF THE SUBSCAPULARIS AND THE INFRASPINATUS TENDONS WITH A FOCAL DEFECT OF THE HUMERAL HEAD. THE PATIENT UNDERWENT HUMERAL HEAD REPLACEMENT. HISTOPATHOLOGIC EXAMINATION OF THE COLLAPSED REGION OF THE HUMERAL HEAD SHOWED NECROSIS, DEGENERATION, FIBRILLATION, AND GRANULATION IN THE CARTILAGE AND TRABECULAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010400 UNK - IMPLANTS SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention