BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 10X140

    MDR report key: 3870406 · Received June 12, 2014

    Report

    Report Number
    0001825034-2014-05484
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    November 10, 2010
    Report Date
    June 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "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 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02364/-02365/-02366/-05484).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, AND METALLOSIS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2010 LEFT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE TO PAIN FROM THE ANGLE OF THE STEM. OPERATIVE REPORT FURTHER NOTED THE PRESENCE FIBROUS TISSUE AND SCAR TISSUE AND THERE WERE NO SCRATCHES PRESENT ON THE HEAD. ONLY THE STEM WAS REMOVED AND REPLACED. OPERATIVE REPORT FOR THE (B)(6) 2013 REVISION NOTED THE REVISION WAS DUE TO PAIN AND FURTHER NOTED THE PRESENCE OF BLOOD-TINGED FLUID, A TROCHANTERIC BURSA AND FRACTURE OF THE POSTERIOR AND ANTERIOR WALL. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A COMPETITOR¿S ACETABULAR COMPONENTS AND A BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348189 TAPERLOC POR FMRL LAT 10X140 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 510030

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R