BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX CERAMIC MODULAR HEAD

    MDR report key: 1153246 · Received September 5, 2008

    Report

    Report Number
    3006946279-2008-00001
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MRA
    PMA / PMN Number
    P050009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DEVICE WAS NOT RETURNED TO MANUFACTURER, BIOMET. DEVICE WAS RETURNED TO U.S. AGENT (BIOMET, INC.) FOR EVALUATION ON 08/22/2008, HOWEVER EVALUATION WAS INCONCLUSIVE. THE DEVICE WAS FORWARDED TO SUPPLIER ON BEHALF OF BIOMET AND UPON RECEIPT OF EVALUATION RESULTS OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE FILED. THE CAUSE OF THE RETURNED DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP PROCEDURE IN 2005. IN 2008, WHILE GOING UPSTAIRS, THE PATIENT EXPERIENCED PAIN AND LIMITATION IN WALKING. SUBSEQUENTLY, REVISION PROCEDURE WAS PERFORMED FOUR DAYS LATER. DURING REVISION PROCEDURE, CERAMIC MODULAR HEAD COMPONENT WAS REMOVED DUE TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX CERAMIC MODULAR HEAD MRA BIOMET FRANCE S.A.R.L. NA 0000169236

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R