BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM

    MDR report key: 6238901 · Received January 10, 2017

    Report

    Report Number
    0001825034-2017-00008
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    May 19, 2015
    Report Date
    January 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS REVEALED NO RECORDED ANOMALY. EXPLANT DATE - N/A. PMA 5510(K): THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY ZIMMER BIOMET IN THE U.S. UNDER K090757. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT MAY OCCUR. UNDER POSSIBLE ADVERSE EVENTS, NUMBER 15 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE LEFT HIP POST-IMPLANTATION. THE PATIENT WAS TREATED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22187 ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM PROSTHETIC, HIP KWA BIOMET ORTHOPEDICS N/A 840410

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention