BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3193519 · Received June 27, 2013

    Report

    Report Number
    0001825034-2013-02382
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    October 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS LIMITED INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR. (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(6) CLINICAL STUDY. PLEASE SEE ATTACHED ABSTRACT TITLED ¿PREVALENCE AND PREDICTORS OF PSEUDOTUMOR AND ELEVATED METAL ION LEVELS FOLLOWING LARGE-DIAMETER HEAD METAL-ON-METAL TOTAL HIP ARTHROPLASTY¿.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION AND INITIAL PROCEDURE DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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." THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02382 & 05331 / 05333).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR. (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. DURING POST OPERATIVE MONITORING AND TESTING, A MIXED MASS WAS NOTED. THE MASS MEASURED 3.3 X 4.6 X 2.5CM ON THE ANTERIOR AREA OF THE LEFT HIP. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. DURING POST OPERATIVE MONITORING AND TESTING, A MIXED MASS WAS NOTED. THE MASS MEASURED 3.3 X 4.6 X 2.5 CM ON THE ANTERIOR AREA OF THE LEFT HIP. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293641 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 406660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R