BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS HIP STEM 38-C

    MDR report key: 7274775 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-00577
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 9, 2017
    Report Date
    May 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK130610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. REVIEW OF X-RAYS INDICATE RADIOLUCENCY AND MALPOSITION OF THE STEM. DEVICE HISTORY RECORD (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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH - 1939. CONCOMITANT MEDICAL PRODUCTS: XL-053250, RLOC-X ARCOMXL H/W 50/32MM 23, 3038546, 131350, EXC ABT RNGLC-X SHELL PC 050MM, 3417600, 650-1162, DELTA CER FEM HD 32/0MM T1, 3386519. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP APPROXIMATELY TWO YEARS POST-IMPLANTATION AND WAS DIAGNOSED WITH TROCHANTERIC BURSITIS. PATIENT WAS TREATED WITH A STEROID BLOCK. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115848 SIRIUS HIP STEM 38-C PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 076340

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention ITEM # UNK, BCM-PALACOS-UNKNOWN-UNK, LOT # UNK