BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -3MM NK

    MDR report key: 2845754 · Received November 26, 2012

    Report

    Report Number
    0001825034-2012-02489
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02488 / 02489).

    Additional Manufacturer Narrative · 1

    (B)(4) - EVALUATION OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF DESIGN SPECIFICATIONS. DEVELOPMENT ENGINEER WAS CONSULTED AND STATED THAT THIS WOULD HAVE NO EFFECT ON THE FUNCTION OF THE ASSEMBLY, AND WOULD NOT HAVE ANY EFFECT ON THE PATIENT DISLOCATING.THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02488-1 / 02489-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2012 DUE TO DISLOCATION. THE BI-POLAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 28MM DIA COCR MOD HD -3MM NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 296560

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R