BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC POROUS FEMORAL 9X125MM

    MDR report key: 3851863 · Received June 5, 2014

    Report

    Report Number
    0001825034-2014-05274
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 4 STATES, ¿IMPLANTS CAN LOOSEN OR MIGRATE DUE TO TRAUMA OR LOSS OF FIXATION.¿ NUMBER 7 STATES, ¿PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC OR POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR LIQUID. IT HAS BEEN REPORTED THAT THIS WEAR DEBRIS MAY INITIATE A CELLULAR PROCESS RESULTING IN OSTEOLYSIS OR IT MAY BE PRESENT AS A RESULT OF LOOSENING OF THE IMPLANT." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05272 / 05274).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 1995. SUBSEQUENTLY, A REVISION OCCURRED ON (B)(6) 2014 DUE TO WEAR OF THE LINER, POORLY FIXATED STEM WITH PROXIMAL LYSIS, AND MALPOSITIONED CUP WITH LYSIS BEHIND THE CUP. THE POLYETHYLENE LINE, ACETABULAR CUP AND STEM WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328525 BI-METRIC POROUS FEMORAL 9X125MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 414020

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R