BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ LTD 52MM SZ 23

    MDR report key: 3920118 · Received July 8, 2014

    Report

    Report Number
    0001825034-2014-06049
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    November 13, 2012
    Report Date
    June 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MEH
    PMA / PMN Number
    PK070369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 RELATED TO THE EVENT.THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2012 DUE TO THE CUP BEING ASEPTICALLY LOOSE. IT WAS REPORTED THAT THE STEM REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398162 REGEN/RNGLC+ LTD 52MM SZ 23 PROSTHESIS, HIP MEH BIOMET ORTHOPEDICS N/A 423260

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R