BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM +3 HIWALL LNR SZ24

    MDR report key: 3026065 · Received March 28, 2013

    Report

    Report Number
    0001825034-2013-00787
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00786 / 00787).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED DATA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00786-1 / 00787-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH COMPETITOR PRODUCTS. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO PAIN AND MALALIGNED CUP. THE CUP WAS REMOVED AND REPLACED WITH A BIOMET CUP. ON (B)(6) 2011, PATIENT WAS REVISED DUE TO INSTABILITY AND THE HEAD AND STEM WERE REPLACED WITH COMPETITOR PRODUCT AND A BIOMET LINER WAS IMPLANTED. ON (B)(6) 2013, THE PATIENT WAS REVISED DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO PAIN AND MALALIGNED CUP. THE CUP WAS REMOVED AND REPLACED WITH A BIOMET CUP. ON (B)(6) 2011, PATIENT WAS REVISED DUE TO INSTABILITY AND THE HEAD AND STEM WERE REPLACED WITH COMPETITOR PRODUCT AND A BIOMET LINER WAS IMPLANTED. ON (B)(6) 2013, THE PATIENT WAS REVISED DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129347 E-POLY 40MM +3 HIWALL LNR SZ24 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 462800

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R