BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -6MM NK

    MDR report key: 2903809 · Received January 9, 2013

    Report

    Report Number
    0001825034-2013-00075
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 17, 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

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. 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 1825034-2013-00074 / 00075).

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00074-1 / 00075-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED WITH ANOTHER BIOMET HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11529 28MM DIA COCR MOD HD -6MM NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 674480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R