BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD +3MM NK

    MDR report key: 3379832 · Received October 1, 2013

    Report

    Report Number
    0001825034-2013-04337
    Event Type
    Injury
    Date Received
    October 1, 2013
    Date of Event
    September 9, 2010
    Report Date
    September 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. 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.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01345-1/01346-1 AND 04336/04338).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2010, DUE TO ALLEGED PAIN AND BONE AND TISSUE DESTRUCTION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2010 WAS DUE TO ACETABULAR CUP LOOSENING. SURGEON NOTED BURSA, BLACK STAINED TISSUE, BONY CYSTS AND FLUID PRESENT IN THE JOINT. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. MEDICAL RECORDS ALSO STATE THIS IS A BILATERAL PATIENT. INVOICE HISTORY CONFIRMS THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROLPLASTY ON (B)(6) 2004. NO REVISION OF THE RIGHT SIDE IS ALLEGED. 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
    494726 M2A 38MM MODULAR HEAD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 444170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R