BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 3752139 · Received April 15, 2014

    Report

    Report Number
    0001825034-2014-02813
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    June 26, 1998
    Report Date
    September 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - 1989. PMA/510(K) NUMBER . MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00799 & 02813).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00799-2 / 02813-1).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS IN THE JOINT ASSIST DATABASE. IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY IN 1989. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 1998 DUE TO AN UNKNOWN REASON. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2008, DUE TO POLY WEAR, INSTABILITY AND PAIN. THE ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS IN THE JOINT ASSIST DATABASE. IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY IN 1989. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 1998 DUE TO AN UNKNOWN REASON. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)6() 2008 DUE TO POLY WEAR, INSTABILITY AND PAIN. THE LINER, LOCKING RING, AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 DUE TO SUBLAXATION AND PAIN. OPERATIVE REPORT FURTHER NOTED DAMAGE TO THE LOCKING MECHANISM OF THE CONSTRAINED LINER AND LOOSE CERCLAGE WIRES DURING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229014 UNKNOWN HEAD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R