BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW

    MDR report key: 3475397 · Received November 18, 2013

    Report

    Report Number
    1221934-2013-00335
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Report Date
    November 13, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILE TO CAPTURE A HISTORICAL EVENT THAT TOOK PLACE SOMETIME IN 2008 AND WAS CAPTURED BY OUR MEDICAL SAFETY OFFICER FROM A PUBLISHING. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE FOLLOWING ISSUE WAS DISCOVERED VIA A PUBLISHED INDIVIDUAL CASE REPORT BY THE MITEK SAFETY OFFICER: INDIVIDUAL CASE REPORTS (COMPLICATIONS). PATIENTS CHARACTERISTICS: SONG ET AL. (2008) ¿ KOREA (B)(6), FEMALE, LARGE SPURS ON THE GREATER TUBEROSITY AND ANTERIOR ACROMION SUPRASPINATUS TEAR (MRI). OPERATIVE COMPLICATIONS: SONG ET AL. (2008) SHOULDER BIOCORKSCREW SUTURE PASSER: EXPRESSEW SUBACROMIAL DECOMPRESSION, DUAL ROW REPAIR OF SUPRASPINATUS, REPAIR OF SUBSCAPULARIS. TINY METAL PARTICLE ON POSTOPERATIVE X-RAY (4 MM) POSTOPERATIVE COMPLICATIONS: SONG ET AL. (2008) SHOULDER 2 YEARS X-RAY: METAL PARTICLE REMAINED AT SUPERIOR PORTION OF SHOULD JOINT WITHOUT EVIDENCE OF MIGRATION OR GLENOHUMERAL JOINT CHANGES NONE, PATIENT DID NOT REQUEST TO REMOVE FOREIGN BODY FUNCTIONAL OUTCOMES: SONG ET AL. (2008) SHOULDER ROM SYMMETRIC WITH OPPOSITE SIDE ASES: 38/100 TO 92/100 UCLA: 15/35 TO 32/35 PAIN OR LIMITATION WHEN REACHING UPPER BACK SORENESS AFTER LENGTHY PERIODS OF USE SATISFIED ASES - AMERICAN SHOULDER AND ELBOW SURGEONS. UCLA - UNIVERSITY OF CALIFORNIA AT LOS ANGELES. ADDRESS CORRESPONDENCE AND REPRINT REQUESTS TO HYUN-SEOK SONG, M.D., DEPARTMENT OF ORTHOPAEDIC SURGERY, ST. PAUL¿S HOSPITAL, THE CATHOLIC UNIVERSITY OF KOREA, 620-56 JEONNONG-DONG, DONGDAEMUN-GU, SEOUL, KOREA, 130-709. E-MAIL: HSSONGMD@ YAHOO.COM THE PATIENT MAY HAVE BEEN OPERATED BY MATTHEW L. RAMSEY, M.D. AT THE ROTHMAN INSTITUTE OF ORTHOPEDICS AT THOMAS JEFFERSON UNIVERSITY, PHILADELPHIA, PENNSYLVANIA, U.S.A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596026 MITEK EXPRESSEW ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR