BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR ACETABULAR CUP 28MM I.D. / 51MM O.D.

    MDR report key: 2231838 · Received September 1, 2011

    Report

    Report Number
    1825034-2011-00770
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    June 27, 2009
    Report Date
    August 8, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K051569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO CORRECT THE DESCRIPTION OF THE EVENT. THIS REPORT SUBMITTED (B)(6) 2011.

    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 WARNINGS, NUMBER ONE STATES, "THE RINGLOC BI-POLAR ACETABULAR PROSTHESIS CAN DISLOCATE. CLOSED REDUCTION IS GENERALLY SUCCESSFUL, HOWEVER CLOSED REDUCTION MUST BE ATTEMPTED WITH CAUTION TO PREVENT DISASSOCIATION OF THE BI-POLAR ACETABULAR COMPONENT FROM THE FEMORAL COMPONENT. WHEN DISLOCATED, THE BI-POLAR COMPONENT CAN ASSUME A VERTICAL POSITION AND BECOME IMPINGED AGAINST THE NATURAL ACETABULUM". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS IS MDR ONE OF THREE (1825034-2011-00770 THROUGH 00772) FOR THIS EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LEGAL COMPLAINT THAT PATIENT UNDERWENT HEMI-ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT'S HIP DISLOCATED AND A CLOSED REDUCTION PROCEDURE WAS PERFORMED ON (B)(6) 2009. AN OPEN REDUCTION WAS THEN PERFORMED ON (B)(6) 2009, WITH THE MODULAR HEAD BEING REMOVED AND REPLACED, AFTER PATIENT'S HIP DISLOCATED AGAIN. ON (B)(6) 2009, THE PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT REPORTEDLY EXPIRED ON (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED VIAL LEGAL COMPLAINT THAT PATIENT UNDERWENT HEMI-ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, THE PATIENT'S HIP DISLOCATED AND A CLOSED REDUCTION PROCEDURE WAS PERFORMED ON (B)(6), 2009. AN OPEN REDUCTION WAS THEN PERFORMED ON (B)(6), 2009, WITH THE MODULAR HEAD BEING REMOVED AND REPLACED, AFTER PATIENT'S HIP DISLOCATED AGAIN. ON (B)(6), 2009, THE PATIENT WAS REVISED WITH ALL COMPONENTS REMOVED AND REPLACED, DUE TO DISLOCATION. PATIENT REPORTEDLY EXPIRED ON (B)(6), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC BI-POLAR ACETABULAR CUP 28MM I.D. / 51MM O.D. PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 256690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R