BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X44MM

    MDR report key: 7561431 · Received June 1, 2018

    Report

    Report Number
    0001825034-2018-03407
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    May 8, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X RAYS. X-RAY REVIEW IDENTIFIED SUPERIOR DISLOCATION OF THE FEMUR FROM THE ACETABULAR CUP. IT WAS FOUND THAT THE FEMORAL HEAD APPEARS SLIGHTLY SMALLER FOR THE SIZE OF THE CUP. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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). CONCOMITANT MEDICAL PRODUCTS: 110024464, G7 DUAL MOBILITY LINER 44MM F, 123300, 010000705, G7 BONEMASTER LTD ACET SHL 56F, 3770228, GM09005-200-01, GLOBAL CERAMIC FEMORAL HEAD, 1710CH-3, GM08001-203-09, GLOBAL PARAGON COLLARED PCHA, 178PS-169. (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S RIGHT HIP WAS REVISED FOUR DAYS POST IMPLANTATION DUE TO DISLOCATION. SURGEON REMOVED HEAD AND BEARING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405584 ACT ARTIC E1 HIP BRG 28X44MM PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 719400

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R