BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 ACTIVE ARTICULATION HEAD 28MM ID X 38MM OD

    MDR report key: 2151074 · Received July 6, 2011

    Report

    Report Number
    1825034-2011-00547
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED COMPONENT CONFIRMED THAT IT MET SPECIFICATION. EVALUATION OF THE ASSOCIATED TRIAL COMPONENT FOUND THAT IT ALSO MET SPECIFICATION. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY PROCEDURE ON (B)(6), 2011. DURING THE PROCEDURE, THE SURGEON UTILIZED A TRIAL FEMORAL HEAD WITH THE ACETABULAR CUP IMPLANT AND NOTED THAT THE TRIAL WAS STABLE. AN ATTEMPT TO IMPLANT THE SAME SIZED FEMORAL HEAD IMPLANT WAS UNSUCCESSFUL AS IT EASILY DISLOCATED FROM THE ACETABULAR CUP IMPLANT WHEN THE SURGEON RANGED THE HIP AFTER REDUCTION. THE FEMORAL HEAD WAS REMOVED AND ANOTHER FEMORAL HEAD WAS RETRIEVED TO COMPLETE THE PROCEDURE; HOWEVER, A DELAY GREATER THAN THIRTY MINUTES OCCURRED AS A RESULT. EVENT IS BEING REPORTED AS A DELAY IN THE PROCEDURE WAS INDICATED; NO PRODUCT PROBLEM WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E1 ACTIVE ARTICULATION HEAD 28MM ID X 38MM OD PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 453450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R