BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY RLC 36MM 10DEG SZ24

    MDR report key: 3953449 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06353
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    November 13, 2013
    Report Date
    July 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: "FATIGUE FRACTURE OF COMPONENT MAY OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." 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 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06059 /-06060 /-06353)/-06354.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, LEGAL COUNSEL REPORTS THAT PATIENT UNDERWENT LEFT HIP REVISION PROCEDURES ON (B)(6) 2013 DUE TO PATIENT ALLEGATION OF PAIN. A REVIEW OF INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. NO RIGHT SIDE REVISION HAS BEEN REPORTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013, DUE TO A FRACTURED ACETABULAR LINER CONSISTENT WITH TRAUMA. OPERATIVE REPORT NOTED A FRACTURED LINER; HOWEVER, THE CUP WAS STABLE WITH NO LOOSENING OR DAMAGE PRESENT. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. OPERATIVE REPORT FOR THE (B)(6) 2013, LEFT HIP REVISION NOTED THE REVISION WAS DUE TO A FRACTURED ACETABULAR LINER CONSISTENT WITH TRAUMA. OPERATIVE REPORT NOTED THE PRESENCE OF METALLIC DEBRIS AND A FRACTURED LINER; HOWEVER, THE CUP WAS STABLE WITH NO LOOSENING OR DAMAGE PRESENT. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430190 EPOLY RLC 36MM 10DEG SZ24 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 585630

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R