BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 6429965 · Received March 23, 2017

    Report

    Report Number
    0001822565-2017-01823
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    March 21, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWL
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION TO THE CAUSE OF THE EVENT. SOONG JOON LEE, MD, HONG SUK KWAK, MD, JEONG JOON YOO, MD, PHD, & HEE JOONG KIM, MD, PHD (2015). BEARING CHANGE TO METAL-ON-POLYETHYLENE FOR CERAMIC BEARING FRACTURE IN TOTAL HIP ARTHROPLASTY; DOES IT WORK? THE JOURNAL OF ARTHROPLASTY, 31, 204-208. HTTP://WWW.ARTHROPLASTYJOURNAL.ORG/ARTICLE/S0883-5403(15)00793-7/ABSTRACT.

    Description of Event or Problem · 1

    A PATIENT IDENTIFIED IN THE ARTICLE UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE DUE TO PERIPROSTHETIC INFECTION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209203 UNKNOWN STEM HIP PROSTHESIS KWL ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention