BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 3623728 · Received February 12, 2014

    Report

    Report Number
    0001825034-2014-00799
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 16, 2008
    Report Date
    September 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    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

    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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00799-2 / 02813-1).

    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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00799 & 02813).

    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. (B)(4).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS IN THE (B)(6) DATABASE. IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2008 DUE TO POLY WEAR. IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT TWO OF ADDITIONAL SURGERIES PRIOR TO THE REVISION. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THESE PREVIOUS SURGERIES.

    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 SUBLUXATION AND PAIN. OPERATIVE REPORT FURTHER NOTED DAMAGE TO THE LOCKING MECHANISM OF THE CONSTRAINED LINER AND LOOSE CERCLAGE WIRES DURING THE REVISION PROCEDURE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92996 UNKNOWN LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R