BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 14X250MM SPL TPR DIST HA

    MDR report key: 5691478 · Received June 1, 2016

    Report

    Report Number
    0001825034-2016-01857
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    June 7, 2013
    Report Date
    July 6, 2016
    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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE IS NO ALLEGED FAILURE OF THIS DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 3 STATES, "INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE." NUMBER 15 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K090757. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01855 / 01856 / 01857). DEVICE REMAINS IMPLANTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE OF THE FEMORAL SHAFT DURING THE IMPLANTATION OF A LEFT TOTAL HIP AND UNDERWENT A FEMORAL OSTEOTOMY WHICH CREATED A DELAY OF GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346733 ARCOS 14X250MM SPL TPR DIST HA PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 825030

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R