BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-H PC 13X170MM T1

    MDR report key: 4843587 · Received June 15, 2015

    Report

    Report Number
    3002806535-2015-00260
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    June 29, 2012
    Report Date
    May 21, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2012 DUE TO STEM SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388790 M-H PC 13X170MM T1 PROTHESIS, HIP LZO BIOMET UK LTD. N/A 2297431

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R