BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX48MM CUP

    MDR report key: 3780998 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03429
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    November 13, 2013
    Report Date
    July 14, 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
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT / LOT CODE / EXPIRATION DATE - UNKNOWN, PMA/510(K) NUMBER - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03429 AND -06436).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, TISSUE AND BONE DESTRUCTION, AND DIFFICULTY WALKING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S REVISION OPERATIVE REPORT REVEALS THE PRESENCE OF PELVIC PERIACETABULAR BONE LOSS SECONDARY TO OSTEOLYSIS, GRAY COLORED SYNOVIAL FLUID, METALLOSIS, ECCENTRIC WEAR WITHIN THE ACETABULUM, AND BLACK OSTEOLYTIC TISSUE. THE MODULAR HEAD WAS 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 A TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, TISSUE AND BONE DESTRUCTION, AND DIFFICULTY WALKING. 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
    259709 M2A 38MMX48MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 782300

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R