BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRMRS NCK STEM TI BM SZ 30 RSA

    MDR report key: 7412359 · Received April 10, 2018

    Report

    Report Number
    3002806535-2018-00690
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    April 8, 2013
    Report Date
    April 10, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    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

    (B)(4). REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION OR MARKETED IN THE US. HOWEVER, THE DEVICE IS SIMILAR TO TAPERLOC HIP SYSTEM (K050441, JDI). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CLINICAL STUDY 490 THE PATIENT EXPERIENCED PAIN WITH DIFFICULTY PERFORMING DAILY ACTIVITIES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262722 PRMRS NCK STEM TI BM SZ 30 RSA PROSTHESIS, HIP LZO BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other UNKNOWN PART/LOT, HEAD, LINER, CUP