BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD STD NK

    MDR report key: 3821880 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04419
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    February 21, 2011
    Report Date
    July 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    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 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 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04419 / 04420, 4423).

    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. THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04419 /-04420 /- 04423 /-04421).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND A REVISION PROCEDURE ON (B)(6) 2011 AND (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DYSFUNCTION, ELEVATED METAL ION LEVELS, LACK OF MOBILITY, AND LOSS OF RANGE OF MOTION. 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 PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND A REVISION PROCEDURE ON (B)(6) 2011 AND (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, DYSFUNCTION, ELEVATED METAL ION LEVELS, LACK OF MOBILITY, AND LOSS OF RANGE OF MOTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2011 DUE TO PAIN. OPERATIVE REPORT NOTED THE PRESENCE OF FLUID. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A ADDITIONAL RIGHT HIP REVISION ON (B)(6) 2011 DUE TO PAIN AND ACETABULAR LOOSENING. OPERATIVE REPORT NOTED THE PRESENCE OF FLUID, INFLAMMATION AND BONE LOSS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300104 M2A 38MM MOD HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 518340

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R