BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 32MM RLC LNR MROM SZ23

    MDR report key: 3842578 · Received June 2, 2014

    Report

    Report Number
    0001825034-2014-05079
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    December 9, 2013
    Report Date
    July 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05079 AND 06258).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT 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 PATIENT ALLEGATIONS OF PAIN. A REVIEW OF THE INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND INDICATES THE ACETABULAR LINER WAS REMOVED AND REPLACED WITH A CONSTRAINED LINER DURING THE REVISION PROCEDURE. 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 PATIENT REPORTED PATIENT UNDERWENT A RIGHT 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 PATIENT ALLEGATIONS OF PAIN. A REVIEW OF THE INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND INDICATES THE ACETABULAR LINER WAS REMOVED AND REPLACED WITH A CONSTRAINED LINER DURING THE REVISION PROCEDURE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN AND FEMORAL LOOSENING. THE PATIENT'S OPERATIVE REPORT NOTED LINER AND FEMORAL STEM WERE REMOVED. THE FEMORAL STEM WAS REPLACED WITH A COMPETITOR'S STEM COMPONENT. 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
    320972 ARCOMXL 32MM RLC LNR MROM SZ23 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 745160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R