BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP PF FEMORAL HEAD RESURF 40MM

    MDR report key: 2842548 · Received November 21, 2012

    Report

    Report Number
    0001825034-2012-02442
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    July 3, 2012
    Report Date
    November 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK023188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH, 0001825034-2012-02442, IS A DUPLICATE OF MEDWATCH 0001825034-2013-04203. THIS MEDWATCH, 0001825034-2012-02442, IS CONSIDERED CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02441 & 02442).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO ELEVATED COBALT CHROMIUM LEVELS. THE ACETABULAR CUP AND FEMORAL HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 ALLEGEDLY DUE TO ELEVATED COBALT CHROMIUM LEVELS. THE ACETABULAR CUP AND FEMORAL HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECAP PF FEMORAL HEAD RESURF 40MM PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 793140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R