BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +9MM

    MDR report key: 3910092 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05920
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 8 STATES: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS".

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386931 36MM COCR MOD HD +9MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 209420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R