BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 36MM RLC LNR +5MM SZ26

    MDR report key: 3863727 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05266
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 29, 2011
    Report Date
    May 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05263, 05264 & 05266).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2006. A REVIEW OF INVOICE HISTORY CONFIRMED THE REVISION SURGERY DATE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE INITIAL SURGERY DATE AND WHICH COMPONENTS WERE REMOVED AND REPLACED. IT FURTHER INDICATES THAT PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2011. INVOICE HISTORY SUGGESTS THAT ALL COMPONENTS WERE REMOVED AND REPLACED WITH BIOMET PMI COMPONENTS ON (B)(6) 2011. 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
    339896 ARCOMXL 36MM RLC LNR +5MM SZ26 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 398760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R