BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 6801033 · Received August 17, 2017

    Report

    Report Number
    0001825034-2017-06480
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    April 24, 2017
    Report Date
    August 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS IDENTIFIED DURING REVIEW OF A JOURNAL ARTICLE. HIROFUMI OSHIMA, MD A, B, SAKAE TANAKA, MD, PHD A, YOSHIO TAKATORI, MD, PHD B, TAKEYUKI TANAKA, MD A, HISATOSHI ISHIKURA, MD A, TORU MORO, MD, PHD, ET AL. CLINICAL AND RADIOGRAPHIC OUTCOMES OF TOTAL HIP ARTHROPLASTY WITH A SPECIFIC LINER IN SMALL ASIAN PATIENTS: INFLUENCE OF PATIENT-RELATED, IMPLANT-RELATED, AND SURGICAL FACTORS ON FEMORAL HEAD PENETRATION CONCOMITANT MEDICAL PRODUCTS: UNKNOWN MALLORY CUP, UNKNOWN ARCOM LINER, UNKNOWN BI-METRIC STEM. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034- 2017- 05798, 0001825034 - 2017 - 06481, 0001825034 - 2017 - 06488.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 4 PATIENTS EXPERIENCED DEEP VEIN THROMBOSIS WITHOUT ASSOCIATED PULMONARY EMBOLISM, WHICH WERE TREATED SUCCESSFULLY WITH ANTICOAGULANTS IN EACH CASE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580773 UNKNOWN HEAD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other