BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 18X150MM SPL TPR DIST HA

    MDR report key: 6153087 · Received December 7, 2016

    Report

    Report Number
    0001825034-2016-05078
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    April 25, 2015
    Report Date
    July 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED UNDER 510K NUMBER K090757. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05077 / 05078).

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF MFR NUMBER 0001825034-2017-01431. THIS REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP ARTHROPLASTY . SUBSEQUENTLY PATIENT EXPERIENCED FEMORAL PAIN 6 MONTHS POST-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803233 ARCOS 18X150MM SPL TPR DIST HA PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 928620

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention