BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 MAXROM LINER SIZE23

    MDR report key: 3250414 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02943
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 27, 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
    CO, 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. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-02943 AND 02946).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE RECEIVING BIOMET AND COMPETITOR PRODUCTS. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO AN UNKNOWN REASON. REVIEW OF INVOICE HISTORY INDICATES THE BIOMET LINER WAS REMOVED AND REPLACED. IT IS FURTHER REPORTED PATIENT UNDERWENT A SECOND REVISION (B)(6) 2013 DUE TO A FRACTURED LINER. THE LINER AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349630 E-POLY 36MM +3 MAXROM LINER SIZE23 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 475060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R