BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 3007495 · Received March 15, 2013

    Report

    Report Number
    0001825034-2013-00630
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 20, 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

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EXAMINATION OF THE RETURNED DEVICES FOUND LITTLE EVIDENCE OF BONY INGROWTH ON THE CUP. THE HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. BASED UPON THE APPEARANCE OF THE PARTS, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00629-1 / 00631-1).

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. 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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00629 / 00631).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN, LOOSENING, AND PSEUDOTUMOR. THE CUP, HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109211 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 323220

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R