BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 48MM

    MDR report key: 3830649 · Received May 23, 2014

    Report

    Report Number
    0001825034-2014-04780
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 15, 2014
    Report Date
    October 7, 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
    TX, 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 ASSOCIATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 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 NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04779 / 04780).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04779 / -04780 AND -08408 / -08409).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, STIFFNESS AND GRINDING IN HIP. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 AND THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF INVOICE HISTORY INDICATES PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6) 2005 DUE TO UNKNOWN REASONS. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. RECORDS SHOW PATIENT UNDERWENT ANOTHER REVISION PROCEDURE (B)(6) 2008 DUE TO UNKNOWN REASONS. ALTHOUGH THE SIDE COULD NOT BE DETERMINED, THIS IS LIKELY A SUBSEQUENT RIGHT HIP REVISION. THE MODULAR HEAD AND RINGLOC LINER WERE REMOVED AND REPLACED. IN ADDITION, REVIEW OF THE INVOICE HISTORY CONFIRMS THE REPORTED (B)(6) 2014 REVISION PROCEDURE AND SHOWS THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR COMPONENT.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, STIFFNESS AND GRINDING IN HIP. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 AND THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. 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
    308748 M2A-MAGNUM MOD HEAD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 867280

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R