BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD ANT STBLZD BRG 12X75

    MDR report key: 3963522 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06494
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    March 13, 2013
    Report Date
    July 28, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK050222
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    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.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06493 & 06494).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF LOOSENING, INSTABILITY AND BANGING SOUNDS. DURING THE PROCEDURE, THE BEARING WAS REMOVED AND REPLACED AND A LOCKING BAR WAS IMPLANTED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED BY PATIENT NOTED THAT PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF LOOSENING, INSTABILITY AND BANGING SOUNDS. SUBSEQUENTLY, PATIENT ALLEGES LOOSENING, INSTABILITY, AND BANGING SOUNDS PERSIST; HOWEVER, A SECOND REVISION PROCEDURE HAS NOT BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF LOOSENING, INSTABILITY AND BANGING SOUNDS. DURING THE PROCEDURE, THE BEARING WAS REMOVED AND REPLACED AND A LOCKING BAR WAS IMPLANTED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442005 VNGD ANT STBLZD BRG 12X75 PROSTHESIS, HIP JWH BIOMET ORTHOPEDICS N/A 767050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R