BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -6MM NECK

    MDR report key: 4192499 · Received October 22, 2014

    Report

    Report Number
    0001825034-2014-08209
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    March 31, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, "UNDESIRABLE SHORTENING OF LIMB," AND ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-08209 / -08210).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ONCOLOGY PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 DUE TO TUMOR REMOVAL. ON (B)(6) 2014, THE PATIENT UNDERWENT A REVISION PROCEDURE TO CORRECT A LEG LENGTHENING ISSUE. SUBSEQUENTLY, THE PATIENT HAS DISLOCATED AND IS NEED OF A SUBSEQUENT REVISION. A DATE HAS NOT BEEN SET FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671586 32MM MOD HEAD COCR -6MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 968560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R