BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32M ALUMINA HD 12/14TPR MEDIUM

    MDR report key: 5141953 · Received October 9, 2015

    Report

    Report Number
    0001825034-2015-04267
    Event Type
    Injury
    Date Received
    October 9, 2015
    Report Date
    September 16, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PP050009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. DATE OF EVENT - PROCEDURE HAS NOT YET OCCURRED. DATE EXPLANTED - DEVICE STILL IMPLANTED. PRODUCT IDENTIFICATION IS UNCERTAIN. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 352410; EXPIRATION DATE - NOV 30, 2015; DATE IMPLANTED - (B)(6) 2006; MANUFACTURE DATE ¿ NOV 21, 2005. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 423450; EXPIRATION DATE - NOV 30, 2015; DATE IMPLANTED - (B)(6) 2006; MANUFACTURE DATE ¿ DEC 2, 2005. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS, NUMBER 13 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING CAN OCCUR. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04267 / 04268).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2006 AND (B)(6) 2006. SUBSEQUENTLY, PATIENT'S RIGHT HIP HAS DISLOCATED AND THE PATIENT IS NOW BOUND TO A WHEEL CHAIR. THE SURGEON IS RECOMMENDING REVISION; HOWEVER, NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670604 32M ALUMINA HD 12/14TPR MEDIUM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R