BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 7747217 · Received August 3, 2018

    Report

    Report Number
    0001825034-2018-05489
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    December 18, 2012
    Report Date
    August 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCOS CON SZ E HI 60MM, PN 11-301315 LN 391010; ARCOS 17X150MM SPL TPR DIST, PN 11-300817 LN 660910; REGENEREX RINGLOC + MULTI HOLE, PN UNKNOWN LN UNKNOWN; FREEDOM TYPE I TAPER, PN UNKNOWN LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-05486; 0001825034-2018-05487; 0001825034-2018-05488; 0001825034-2018-05490. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT LEFT HIP UNDERWENT IRRIGATION AND DEBRIDEMENT DUE TO INFECTION ON APPROXIMATELY ONE MONTH POST-IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590452 UNKNOWN LINER PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other