BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM

    MDR report key: 6401340 · Received March 13, 2017

    Report

    Report Number
    0001825034-2017-01431
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    April 25, 2015
    Report Date
    November 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K090757. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY EXPERIENCED LEFT HIP FEMORAL PAIN 4 MONTHS POST-IMPLANTATION. THE PATIENT WAS MONITORED THROUGH RADIOGRAPHY AND CLINICAL FOLLOW UP. ALTHOUGH THE STEM WAS NOTED TO HAVE TURNED SLIGHTLY VARUS, TREATMENT RESOLVED 7 MONTHS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE AND NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181566 ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 928620

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other