BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRMRS NCK STEM TI BM SZ 24 RSA

    MDR report key: 5746418 · Received June 23, 2016

    Report

    Report Number
    3002806535-2016-00382
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    March 22, 2013
    Report Date
    May 27, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K050441.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. DURING POST-OPERATIVE MONITORING AND TESTING, THE PATIENT EXPERIENCED DEEP VEIN THROMBOSIS APPROXIMATELY THREE MONTHS POST-IMPLANTATION. THE PATIENT WAS GIVEN MEDICATION FOR SIX MONTHS AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399339 PRMRS NCK STEM TI BM SZ 24 RSA PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 2482200

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention