BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ACETABULAR SHELL WITH PLUG 44MM/SOLID W/APICAL DOME HOLE

    MDR report key: 1903896 · Received November 20, 2010

    Report

    Report Number
    1825034-2010-00607
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    November 5, 2008
    Report Date
    October 21, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K921301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    ATTORNEY

    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: LATE POSTOPERATIVE COMPLICATIONS CAN INCLUDE - WEAR OR DEFORMATION OF THE ARTICULAR SURFACES MAY OCCUR AS A RESULT OF EXCESSIVE LOADING. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 1999. SUBSEQUENTLY, RADIOGRAPHS REVEALED POLY WEAR AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008. THE ACETABULAR CUP AND POLYETHYLENE LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL ACETABULAR SHELL WITH PLUG 44MM/SOLID W/APICAL DOME HOLE PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 942720

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R