BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TRI-SPIKE CUP 50MM O.D. X 44MM I.D.

    MDR report key: 2190494 · Received August 4, 2011

    Report

    Report Number
    1825034-2011-00671
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K062995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO REPORT REVISION DATE. (B)(4).

    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, (B)(4) STATES,"INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." (B)(4) STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS IS MDR ONE OF THREE (1825034-2011-00671 THROUGH 00673) FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009. SUBSEQUENTLY, PATIENT REPORTED ELEVATED COBALT LEVELS, POPPING, SQUEAKING, AND HIP PAIN. NO REVISION PROCEDURE HAS BEEN REPORTED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009. SUBSEQUENTLY, PATIENT REPORTED ELEVATED COBALT LEVELS, POPPING, SQUEAKING, AND HIP PAIN. PATIENT WAS REVISED ON (B)(6) 2011. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM TRI-SPIKE CUP 50MM O.D. X 44MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 188170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R