BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM -6

    MDR report key: 2964561 · Received February 15, 2013

    Report

    Report Number
    0001825034-2013-00277
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    July 24, 2012
    Report Date
    August 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    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 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 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00277, 00279 & 00280).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION FROM THE MEDICAL RECORDS AND BLOOD TESTS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012 ALLEGEDLY DUE TO ELEVATED METAL IONS AND PAIN. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THAT THE MODULAR HEAD WAS REMOVED AND REPLACED DURING THE REVISION PROCEDURE ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO PAIN. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. 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 ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012 ALLEGEDLY DUE TO ELEVATED METAL IONS AND PAIN. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THAT THE MODULAR HEAD WAS REMOVED AND REPLACED DURING THE REVISION PROCEDURE. NO OTHER INFORMATION HAS BEEN PROVIDED REGARDING ADDITIONAL REVISION PROCEDURES. 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 ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012 ALLEGEDLY DUE TO ELEVATED METAL IONS AND PAIN. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THAT THE MODULAR HEAD WAS REMOVED AND REPLACED DURING THE REVISION PROCEDURE ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO PAIN. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED AUGUST 12, 2014 REPORTS PATIENT WAS REVISED ON THE RIGHT SIDE (B)(6) 2012 DUE TO METAL ION SYNOVITIS. REVISION OPERATIVE (OP) NOTES REPORT THE PRESENCE LOW LEVEL PROLIFERATION OF SYNOVIUM. IN ADDITION, OP NOTES FOR THE LEFT HIP DATED (B)(6) 2014 REPORT PATIENT WAS REVISED DUE TO METAL-ON-METAL LOCAL ADVERSE TISSUE EFFECTS. REVISION OP REPORT NOTES PSEUDOCAPSULE AND SCAR TISSUE APPEARED THICKENED, YELLOW-TAN IN COLOR, AND IRRITATED. NOTES ALSO REVEAL THAT THE FEMORAL COMPONENT HAD 4 TO 5 DEGREES OF ANTEVERSION AND SIGNS OF EARLY IMPINGEMENT. THE MODULAR HEAD WAS REMOVED AND REPLACED. THE CUP REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66781 SELEX/MAGNUM MODULAR HEAD 40MM -6 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 744990

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R