BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS TAPER ADAPTOR

    MDR report key: 7438392 · Received April 17, 2018

    Report

    Report Number
    0001825034-2018-02807
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    March 19, 2018
    Report Date
    November 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 11-302015, ITEM NAME: ARCOS MODULAR DISTAL HIP STEM, LOT NUMBER: 382530, ITEM NUMBER: 00-2232-004-18, ITEM NAME: CABLE, LOT NUMBER: 63429957, ITEM NUMBER: 163669, ITEM NAME: FEMORAL HEAD, LOT NUMBER: 00J3733117, ITEM NUMBER: CP250315, ITEM NAME: KAESSMANN SCREW, LOT NUMBER: 808100, ITEM NUMBER: CP250316, ITEM NAME: KAESSMAN SCREW, LOT NUMBER: 040530. COMPLAINT REPORTED FROM (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02808. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION DUE TO STEM SUBSIDENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281413 ARCOS TAPER ADAPTOR PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 529950

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R