BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3771441 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03208
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    August 26, 2013
    Report Date
    July 14, 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
    FL, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03207/03208 & 03281).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR; UNDER POSSIBLE ADVERSE EFFECTS: 4. LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. IT WAS ALLEGED THAT IMMEDIATE POST-OPERATIVE RADIOGRAPHS REVEALED THE FEMORAL STEM HAD PIERCED THE FEMORAL SHAFT AND THAT THE PATIENT WAS TAKEN BACK INTO THE O.R. ON THE SAME DAY TO REMOVE AND REPLACE THE FEMORAL STEM. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WITH FLEXION, INFLAMMATION, FIBROSIS, METALLOSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED BOTH SURGERY DATES. INVOICE HISTORY SUGGESTS THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD DURING THE REVISION PROCEDURE ON (B)(6) 2013. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. IT WAS ALLEGED THAT IMMEDIATE POST-OPERATIVE RADIOGRAPHS REVEALED THE FEMORAL STEM HAD PIERCED THE FEMORAL SHAFT AND THAT THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM ON THE SAME DAY TO REMOVE AND REPLACE THE FEMORAL STEM. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WITH FLEXION, INFLAMMATION, FIBROSIS, METALLOSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED BOTH SURGERY DATES. INVOICE HISTORY SUGGESTS THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD DURING THE REVISION PROCEDURE ON (B)(6) 2013. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT HIP REVISION ON (B)(6) 2013 WAS DUE TO ACETABULAR LOOSENING AND MIGRATION. THE PATIENT'S OPERATIVE REPORT NOTED THE LOOSE ACETABULAR COMPONENT, AND A CAVITARY LESION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013 PATIENT'S BLOOD WAS TESTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249233 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 531010

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R