BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 2829580 · Received November 13, 2012

    Report

    Report Number
    0001825034-2012-02399
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    November 18, 2008
    Report Date
    October 17, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WARNINGS, STATES: "MATERIAL SENSITIVITY REACTIONS." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." 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 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-002398 / 02402).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02398/ 02399 & 2013-02901/02902). ADDITIONAL MEDWATCHES FOR THIS PATIENT WERE REPORTED ON MEDWATCH NUMBERS 1825034-2012-02400/2402.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED (B)(6) 2004 AND ANOTHER REVISION ON (B)(6) 2008 DUE TO PAIN, ELEVATED METAL ION LEVELS, INFLAMMATION AND COMPLICATIONS WITH WALKING AND STAIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION PROCEDURE WAS ALLEGEDLY PERFORMED (B)(6) 2004 AND FURTHER REVISION ALLEGEDLY PERFORMED ON (B)(6) 2008 DUE TO ALLEGED PAIN, ELEVATED METAL ION LEVELS, INFLAMMATION AND COMPLICATIONS WITH WALKING AND STAIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2004 WAS DUE TO LEG LENGTH DISCREPANCY. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. MEDICAL RECORDS ALSO INDICATE THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2008 WAS DUE TO METALLOSIS, INSTABILITY AND A RETROVERTED ACETABULAR COMPONENT. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, MODULAR HEAD AND FEMORAL COMPONENT 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
    1 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 191370

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R