BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MLRY-HD W/PG CUP 48X54MM

    MDR report key: 5332242 · Received December 29, 2015

    Report

    Report Number
    0001825034-2015-05194
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    December 7, 2015
    Report Date
    December 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK844941
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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 CAN 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 1994. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 DUE TO LOOSENING OF THE ACETABULAR CUP. DURING THE PROCEDURE THE HEAD, LINER AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855132 28MM MLRY-HD W/PG CUP 48X54MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 830240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R