BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD +12MM NK SKRT

    MDR report key: 3777349 · Received April 29, 2014

    Report

    Report Number
    0001825034-2014-03298
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    July 25, 2013
    Report Date
    October 19, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03301-2 / 03298-2 / 03299-2 / 03300-2).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES."

    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. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO EVENT DETAILS AND PRODUCT IDENTIFICATION ARE IN PROCESS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03298 / 03301)

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2008 AND A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2011. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS A LEFT SIDE REVISION PROCEDURE ON (B)(6) 2013 AND A RIGHT SIDE REVISION PROCEDURE ON (B)(6) 2012. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED DURING EACH REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256884 M2A 38MM MOD HEAD +12MM NK SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 475030

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R