BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 52E

    MDR report key: 4093644 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07734
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 18, 2014
    Report Date
    February 18, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    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 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 A CLINICAL STUDY PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO MIGRATION FROM FAILURE OF INGROWTH. REVIEW OF INVOICE HISTORY VERIFIED THE IMPLANT AND REVISION SURGERY DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573427 G7 PPS LTD ACET SHELL 52E PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3002716

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R