BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 5191391 · Received October 30, 2015

    Report

    Report Number
    0001825034-2015-04445
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    August 29, 2014
    Report Date
    August 22, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 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." NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03206-1 / 04445).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2011. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6), 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, BURSITIS, TISSUE DETERIORATION, AND LIMITED MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S OPERATIVE REPORT INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6), 2014 NOTED EFFUSION DUE TO METAL DEBRIS DURING THE REVISION PROCEDURE. OPERATIVE REPORT ALSO NOTED THE REVISION OF THE ACETABULAR CUP DUE TO MINIMAL BONE INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723215 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 593890

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R D11 MEDICAL PRODUCTS.