BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 38MM RINGLOC MAX-ROM ACETABULAR LINER

    MDR report key: 1902731 · Received November 18, 2010

    Report

    Report Number
    1825034-2010-00573
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    August 17, 2009
    Report Date
    January 8, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. POSSIBLE ADVERSE EFFECT NUMBER 11: WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    INFORMATION RECEIVED SUGGESTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE DUE TO WEAR, OSTEOLYSIS AND LOOSENING OF THE ACETABULAR CUP. REVIEW OF RADIOGRAPHS AND INVOICE HISTORY REVEALED THAT THE PATIENT UNDERWENT A PRIOR REVISION PROCEDURE ON (B)(6) 2008 FOR AN UNKNOWN REASON. SUBSEQUENTLY, PATIENT WAS REVISED AGAIN ON (B)(6) 2009. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-POLY 38MM RINGLOC MAX-ROM ACETABULAR LINER PROSTHESIS, HIP COMPONENT JDI BIOMET ORTHOPEDICS N/A 816980

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Disability| R