BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MODULAR HEAD STD

    MDR report key: 3250416 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02941
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02941 / 02942).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT AN OPEN REDUCTION OF DISLOCATION WITH REVISION OF THE ACETABULAR LINER, EVACUATION OF HEMATOMA, AND OPEN REDUCTION AND INTERNAL FIXATION OF A TROCHANTER FRACTURE ON (B)(6) 2011. THE HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349627 36MM COCR MODULAR HEAD STD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 679450

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R