BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL RINGLOC ACETABULAR LINER 28MM 10 DEGREE SIZE 24

    MDR report key: 2193660 · Received August 5, 2011

    Report

    Report Number
    1825034-2011-00681
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    K051411
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00682). THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP ARTHROPLASTY ON (B)(6), 2010 DUE TO DISLOCATION. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO DISLOCATION. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCOM XL RINGLOC ACETABULAR LINER 28MM 10 DEGREE SIZE 24 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 526690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R