BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR +5 SZ23

    MDR report key: 8347563 · Received February 18, 2019

    Report

    Report Number
    0001825034-2019-00646
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    January 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : CERAMIC FEMORAL HEAD CATALOG#: 650-0836 LOT#: 3202216, FEMORAL STEM CATALOG#: 7100100103BM LOT#: 2013120467, ACETABULAR SHELL CATALOG#: 11-104152 LOT#: 3200276. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED VIA PHOTOGRAPHS RECEIVED. REVIEW OF X-RAYS RECEIVED NOTED SECONDARY SIGNS OF LINER INSTABILITY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART#: (B)(4), DELTA CER FM HD 036/-4MM 12/14, LOT#: 2018031559; PART#: (B)(4), RNGLC LOCKING RING SZ 23, LOT#: 2013120467.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO LINER FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140811 EPOLY 36MM RLC LNR +5 SZ23 HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 909820

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R