BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX RINGLOC 60MM MULTI-HOLE ACETABULAR CUP SIZE 25

    MDR report key: 2173855 · Received July 24, 2011

    Report

    Report Number
    1825034-2011-00598
    Event Type
    Injury
    Date Received
    July 24, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K070369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." EVENT DATE - THERE HAS BEEN NO REVISION TO DATE. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT HIP REVISION ARTHROPLASTY ON (B)(6), 2008 DUE TO PAIN. THE PATIENT CONTINUED TO EXPERIENCE MILD PAIN AND A SUBSEQUENT FOLLOW-UP VISIT WITH THE SURGEON WHERE RADIOGRAPHIC IMAGES WERE TAKEN REVEALED ACETABULAR CUP MIGRATION. NO FURTHER REVISION PROCEDURE HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENEREX RINGLOC 60MM MULTI-HOLE ACETABULAR CUP SIZE 25 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 166070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R