BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MOM HIP

    MDR report key: 4232893 · Received November 6, 2014

    Report

    Report Number
    3002806535-2014-00253
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 15, 2012
    Report Date
    October 7, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. INITIAL REPORTER CONTACT NAME - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034-2017-03317.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT ON THE (B)(6) 2006. SUBSEQUENTLY, A REVISION SURGERY TOOK PLACE ON (B)(6) 2012 DUE TO SEVERE PAIN. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713561 BIOMET MOM HIP PROSTHESIS, HIP LPH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R