BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 2480577 · Received March 6, 2012

    Report

    Report Number
    0001825034-2012-00229
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    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 THAT WOULD RELATE TO THE REPORTED EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. ASSOCIATED PACKAGE INSERT STATES UNDER POSSIBLE ADVERSE EFFECTS: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON MARCH 6, 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00229 THROUGH 00232).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FORWARDED TO RELAY AN ADDITIONAL REASON FOR THE REVISION PROCEDURE AND THE RESULTS OF BLOOD TESTING DONE ON THE PATIENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY". THIS FOLLOW-UP REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00229-1 / 00232-1).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: MATERIAL SENSITIVITY REACTIONS.¿ AND ¿FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COMPLAINT RECEIVED ALLEGING THAT ON (B)(6), 2009 THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. REVISION WAS PERFORMED ON (B)(6), 2012 DUE TO ALLEGED PAIN AND LOOSENING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COMPLAINT RECEIVED ALLEGING THAT ON (B)(6) 2009 THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO ALLEGED PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COMPLAINT RECEIVED ALLEGING THAT ON (B)(6) 2009 THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO ALLEGED PAIN AND LOOSENING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S REVISION MEDICAL RECORDS NOTED THE REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO PAIN. MEDICAL RECORDS FURTHER NOTED THE PRESENCE OF A PSEUDOCAPSULE, DAMAGE AT THE TRUNNION, A LOOSE STEM, A MALPOSITIONED ACETABULAR CUP, INFLAMMATION AND THE ILIOPSOAS TENDON WAS TENTED. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 072620

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R