BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 3921575 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06071
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    October 14, 2010
    Report Date
    July 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: 4. LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04218 AND 06071 / 06072).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND DIFFICULTY SLEEPING AND WALKING. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT RIGHT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2010 WAS DUE TO PAIN AND EVIDENCE OF CUP LOOSENING. THE OPERATIVE REPORT NOTED BROWNISH-YELLOWISH FLUID, CORROSION ON THE FEMORAL NECK, AND A LOOSE CUP. THE HEAD AND CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400412 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 136490

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R