BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS DISTAL SCREW TI DIA5X50MM

    MDR report key: 6024629 · Received October 12, 2016

    Report

    Report Number
    3002806535-2016-00785
    Event Type
    Injury
    Date Received
    October 12, 2016
    Report Date
    September 13, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET IN (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K090757. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER STATES "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 6 OF 6 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04055 / 04056, 04087 AND 04106, 3002806535-2016-00784 / 00785).

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED INFECTION POST-IMPLANTATION AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672125 ARCOS DISTAL SCREW TI DIA5X50MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1829586

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention