BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC Ø54/48MM

    MDR report key: 3231253 · Received July 17, 2013

    Report

    Report Number
    3002806535-2013-00131
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 27, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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. THIS IS 1 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. ALSO SEE: 3002806535-2013-00132.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 3002806535-2016-00573 & 3002806535-2013-00007. THEREFORE, THIS IS NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PSEUDOTUMOR. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330590 RECAP SHELL COCR PC Ø54/48MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 843394

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R