BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B HI 60MM

    MDR report key: 8169057 · Received December 17, 2018

    Report

    Report Number
    0001825034-2018-11004
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    November 21, 2018
    Report Date
    January 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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. 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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 650-1057 CER BIOLOXD OPTION HD 36MM LOT# 2948777, ITEM# 11-300817 ARCOS 17X150MM SPL TPR DIST LOT# 838140, ITEM# 110010268 G7 OSSEOTI MULTIHOLE 60MM G LOT# 6178401, ITEM# 010000859 G7 NEUTRAL E1 LINER 36MM G LOT# 6316641.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF HIP ARTHROPLASTY DUE TO THE PROXIMAL BODY WAS NOT FULLY SEATED FOLLOWING INITIAL PROCEDURE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007544 ARCOS CON SZ B HI 60MM PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 636250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R