BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 5067760 · Received September 10, 2015

    Report

    Report Number
    0001825034-2015-03890
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 20, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO REPORT CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT(S) - BIOMET MAGNUM CUP CATALOG # US157856, LOT #:519720. BIOMET FEMORAL STEM, CATALOG#: 192111, LOT#: 984320. BIOMET TAPER ADAPTER. CATALOG#: 139259, LOT#: 058240.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2015 DUE TO PAIN. THE HEAD AND TAPER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN. DURING THE PROCEDURE, SCAR TISSUE AND METALLOSIS WERE NOTED. THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED, AND AN ACTIVE ARTICULATION BEARING WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598506 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 409290

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R