BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 5243359 · Received November 23, 2015

    Report

    Report Number
    0001825034-2015-04757
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    May 1, 2012
    Report Date
    November 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 28 STATES, "NON-MALIGNANT, NON-INFECTIVE SOFT TISSUE MASSES, SOMETIMES REFERRED TO AS PSEUDOTUMORS." NUMBER 30 STATES, "MATERIAL AND WEAR DEBRIS SENSITIVITY REACTIONS." EVALUATION OF THE RETURNED DEVICE FOUND EVIDENCE OF SCRATCHING OF THE BEARING SURFACES AND METALLIC TRANSFER MARKS. BASED UPON THE APPEARANCE OF THE PARTS, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. ALTHOUGH IT APPEARS THAT SOME TYPE OF THIRD BODY PARTICLE WAS PRESENT, THE SOURCE AND IDENTITY OF THIS AGENT COULD NOT BE ESTABLISHED DURING VISUAL EXAMINATION. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00642 / 2015-04757 - 04759).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, IT WAS FURTHER REPORTED THAT THE ACETABULAR CUP HAD MIGRATED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO LOOSENING. OPERATIVE REPORT FURTHER NOTED A FLUID-FILLED CYSTIC MASS, LOOSE CUP WHICH ROTATED IN THE ACETABULAR CAVITY, AND THE STEM WAS EASILY REMOVED. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774557 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 530410

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R