BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 12.5X145

    MDR report key: 2852049 · Received November 30, 2012

    Report

    Report Number
    0001825034-2012-02511
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 20, 2010
    Report Date
    November 7, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE FEMORAL STEM WAS NOT REMOVED, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED DATA: DATE EXPLANTED - PRODUCT WAS NOT REMOVED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02509 / 02511).

    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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02509 / 02511). 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 REPORTED THAT THE PATIENT UNDERWENT LEFT M2A HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2010 ALLEGEDLY DUE TO PAIN, SQUEAKING, AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2004 WAS DUE TO SQUEAKING, DISLOCATION AND METALLOSIS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. 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 REPORTED THAT THE PATIENT UNDERWENT LEFT M2A HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2010 ALLEGEDLY DUE TO PAIN, SQUEAKING, AND ELEVATED METAL ION LEVELS. 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 TAPERLOC POR LAT FMRL 12.5X145 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 438760

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R