BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRMRS NCK STEM TI BM SZ 24 RSA

    MDR report key: 7428640 · Received April 13, 2018

    Report

    Report Number
    3002806535-2018-00706
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    October 22, 2012
    Report Date
    April 13, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PNOT CLEARED
    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) (B)(6). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION OR MARKETED IN THE US, BUT IS SIMILAR TO TAPERLOC HIP SYSTEM (K050441, JDI). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP SURGERY ON (B)(6) 2012, AND IT WAS REPORTED DURING THE FOLLOWUP THE PATIENT HAD MODERATE PAIN WITH SOME DIFFICULTY PERFORMING DAILY ACTIVITIES DURING 6 MONTH AND 5 YEAR FOLLOW UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272804 PRMRS NCK STEM TI BM SZ 24 RSA PROSTHESIS, HIP JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other UNKNOWN PART/LOT, HEAD, LINER, CUP