BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HD COCR -3MM

    MDR report key: 4152936 · Received October 8, 2014

    Report

    Report Number
    3002806535-2014-00222
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. PRODUCT WAS NOT RETURNED TO MANUFACTURER. 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. THIS REST OF THE REPORTS FOR THIS EVENT ARE FILED BY WARSAW ORTHOPEDICS (REFERENCE 1825034-2014-07764 /-07769).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2001 AND (B)(6) 2002. PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2008 WHERE THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED DUE TO UNKNOWN REASONS. PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2005 WHERE THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED DUE TO UNKNOWN REASONS. SUBSEQUENTLY, PATIENT UNDERWENT AN ADDITIONAL LEFT HIP REVISION ON (B)(6) 2014 DUE TO A DISLOCATION AND FEMORAL FRACTURE CAUSED BY A FALL. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632071 32MM MOD HD COCR -3MM PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 065556

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R