BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX90LH RNGLC SHL 54MM L44

    MDR report key: 3864059 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05412
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK920639
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ASSOCIATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 9 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, THE PATIENT WAS REVISED ON MAY 22, 2014 DUE TO DISCOMFORT. DURING THE REVISION THE SURGEON NOTED LINER WEAR AND REMOVED AND REPLACED THE POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338901 RX90LH RNGLC SHL 54MM L44 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 700250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R