BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ C STD 70MM

    MDR report key: 7752181 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05462
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    July 9, 2013
    Report Date
    March 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVISION OPERATIVE NOTE WAS RECEIVED. IT WAS REPORTED THAT THIS PATIENT WAS REVISED DUE TO A FAILED RIGHT HIP THA SECONDARY TO INSTABILITY. INTRAOPERATIVE EXAMINATION OF THE RIGHT HIP REVEALED INSTABILITY POSTERIORLY WITH FLEXION AND INTERNAL ROTATION. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 28MM MOD HD STD NECK TP1 TAPER, PN 163662, LN 829300; ARCOS CON SZ C STD 70MM, PN 11-301323, LN 942640. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE DEVICES WERE USED IN AN OFF-LABEL MANNER. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED DISLOCATION AND REVISION OF HEAD AND LINER APPROXIMATELY 4 MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594055 ARCOS CON SZ C STD 70MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 942640

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R