BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERAMIC HEAD

    MDR report key: 6778054 · Received August 9, 2017

    Report

    Report Number
    3002806535-2017-00638
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    November 3, 2016
    Report Date
    August 8, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BORGWARDT, A. ET AL (2016) A RANDOMISED, CONTROLLED CLINICAL STUDY ON TOTAL HIP ARTHROPLASTY USING 4 DIFFERENT BEARINGS: RESULTS AFTER 10 YEARS. HIP INTERNATIONAL 2017; 27 (1): 96-103. DOI: 10.5301/HIPINT.5000428. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, 8 PATIENTS IN GROUP D UNDERWENT HIP REVISION DUE TO DISLOCATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560360 UNKNOWN CERAMIC HEAD PROSHTESIS, HEAD LZO BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R