BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MOM PROSTHESIS

    MDR report key: 3943469 · Received July 18, 2014

    Report

    Report Number
    3002806535-2014-00172
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN; IMPLANT DATE - UNKNOWN; MANUFACTURE DATE - UNKNOWN. ITEM HAS BEEN REQUESTED TO BE RETURNED. UPON RECEIPT OF ITEM AND PRODUCT EVALUATION, A FOLLOW-UP MDR WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422248 BIOMET MOM PROSTHESIS PROSTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R