BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD HEAD T1 CERAMIC 28MM - 3MM

    MDR report key: 4113757 · Received September 24, 2014

    Report

    Report Number
    3002806535-2014-00208
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK925345
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY IS OUTSIDE 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. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2001. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO BONE FRACTURE CAUSED BY PATIENT FALL. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594802 MOD HEAD T1 CERAMIC 28MM - 3MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 372046

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R