BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC KNEE IMPLANT

    MDR report key: 3941506 · Received July 17, 2014

    Report

    Report Number
    3002806535-2014-00171
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    April 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED AS ITEMS ARE STILL IMPLANTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL STUDY DEPARTMENT THAT THE PATIENT UNDERWENT A KNEE REPLACEMENT ON (B)(6) 2012. SUBSEQUENTLY THE PATIENT SUFFERED A FRACTURE OF THE FEMUR WHICH IS TOLERATED AND NO REVISION PROCEDURE HAS BEEN PLANNED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418157 AGC KNEE IMPLANT PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention