BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS STS DISTAL STEM

    MDR report key: 6429894 · Received March 23, 2017

    Report

    Report Number
    0001825034-2017-02003
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    July 3, 2015
    Report Date
    September 27, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01998, 0001825034-2017-01999, 0001825034-2017-02002 AND 0001825034-2017-02003.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS DETERMINED EVENT WAS NOT DEVICE NOR PROCEDURE RELATED. PATIENT HAD PRE-EXISTING LUMBAR SCOLIOSIS CONTRIBUTING TO THE CONDITION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED EXPERIENCING LEFT HIP TROCHANTERIC MUSCLE PAIN, LOWER BACK PAIN AND DECREASED FUNCTION APPROXIMATELY ONE YEAR POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211635 ARCOS STS DISTAL STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 964080

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other