BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT RINGLOC-X SHELL

    MDR report key: 6728978 · Received July 20, 2017

    Report

    Report Number
    3002806535-2017-00605
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    March 29, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K042037. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00606.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED SWELLING, PAIN, AND ERYSIPELAS AFTER A TOTAL HIP ARTHROPLASTY. THE PATIENT WAS TREATED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509873 EXCEED ABT RINGLOC-X SHELL PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 3873356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COCR MODULAR HEAD| RINGLOC-X ARCOM LINER| SIRIUS HIP STEM