BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM RINGLOC ACETABULAR +3 HI-WALL SIZE 24

    MDR report key: 1910031 · Received November 30, 2010

    Report

    Report Number
    1825034-2010-00623
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    K090103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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: POSSIBLE ADVERSE EFFECT #4 - LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY. THIS REPORT FILED (B)(6) 2010. - ATTACHMENT:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN (B)(6) 2010. A REVIEW OF SALES AND INVOICE HISTORY REVEALED THAT THE ORIGINAL TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2010. SUBSEQUENTLY, PATIENT REPORTED THAT SHE CAUGHT HER FOOT ON A PIECE OF CARPET WHILE WALKING AND FELT A POP IN HER HIP. SHE DID NOT REPORT PAIN, BUT NOTICED THAT HER HIP BEGAN TO SQUEAK THE NEXT DAY. RADIOGRAPHS CONFIRMED THE LINER HAD DISENGAGED FROM THE SHELL. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 TO REMOVE AND REPLACE THE LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN (B)(6) OF 2010. A REVIEW OF SALES AND INVOICE HISTORY REVEALED THAT THE ORIGINAL TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2010. SUBSEQUENTLY, PATIENT REPORTED THAT SHE CAUGHT HER FOOT ON A PIECE OF CARPET WHILE WALKING AND FELT A POP IN HER HIP. SHE DID NOT REPORT PAIN, BUT NOTICED THAT HER HIP BEGAN TO SQUEAK THE NEXT DAY. RADIOGRAPHS CONFIRMED THE LINER HAD DISENGAGED FROM THE SHELL. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 TO REMOVE AND REPLACE THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-POLY 40MM RINGLOC ACETABULAR +3 HI-WALL SIZE 24 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 301470

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R