BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A HI CARBON HD -3MM NK

    MDR report key: 3901711 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05778
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    September 9, 2007
    Report Date
    July 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05777 / -05778).

    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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. "

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FURTHER REPORTS PATIENT WAS REVISED (B)(6) 2007 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, DYSFUNCTION, SORENESS, LOSS OF RANGE OF MOTION, BODILY IMPAIRMENT, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THE ABOVE REFERENCED DATES AND THAT THE CUP, MODULAR HEAD, AND LINER WERE 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 REPORTED PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FURTHER REPORTS PATIENT WAS REVISED (B)(6) 2007 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, DYSFUNCTION, SORENESS, LOSS OF RANGE OF MOTION, BODILY IMPAIRMENT, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THE ABOVE REFERENCED DATES AND THAT THE CUP, MODULAR HEAD, AND LINER WERE REMOVED AND REPLACED. 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 LEFT HIP REVISION ON (B)(6) 2007 DUE TO PAIN, IMPINGEMENT AND SUBLUXATION. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF A THICKENED CAPSULE. THE ACETABULAR CUP, TAPER LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379703 32MM M2A HI CARBON HD -3MM NK PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 006330

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R