BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ MULTI 54MM SZ 23

    MDR report key: 3984408 · Received August 6, 2014

    Report

    Report Number
    0001825034-2014-06869
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A LOOSE ACETABULAR CUP. THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461945 REGEN/RNGLC+ MULTI 54MM SZ 23 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 013770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R