BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS HIP STEM 34-C

    MDR report key: 9177661 · Received October 10, 2019

    Report

    Report Number
    0001825034-2019-04611
    Event Type
    Injury
    Date Received
    October 10, 2019
    Date of Event
    September 30, 2016
    Report Date
    October 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    PMA / PMN Number
    K130610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:650-0662 LOT NUMBER: 3256336 BRAND NAME: DELTA CERAMIC FEMORAL HEAD, CATALOG NUMBER:131350BM LOT NUMBER:3106556 BRAND NAME: EXCEED RINGLOC SHELL, CATALOG NUMBER:EP-083650 LOT NUMBER:2430446 BRAND NAME: RINGLOC LINER. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT HIP BURSITIS AND LIMITED RANGE OF MOTION APPROXIMATELY 2 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE, PATIENT REMAINS IN CLINICAL STUDY AND IMPLANTED. NO FURTHER REPORTS OF BURSITIS OR ROM ISSUES IN FOLLOWING VISITS. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968137 SIRIUS HIP STEM 34-C PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. N/A 216180

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR