BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 8X145MM

    MDR report key: 3962047 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06474
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01860 AND 06474).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A 522 CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. DURING POST OPERATIVE MONITORING AND TESTING, A MIGRATED ACETABULAR CUP AND FLUID WERE NOTED. THE FLUID ON THE POSTERIOR LATERAL QUADRANT OF THE RIGHT HIP MEASURED 23.4 X 23.3 X 32.9 MM. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437816 MLRY-HD POR FMRL 8X145MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 198040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention