BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR ACETABULAR LINER

    MDR report key: 1000487 · Received February 20, 2008

    Report

    Report Number
    1825034-2008-00065
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K926107
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. EVALUATION OF EXPLANTED DEVICE FOUND EVIDENCE OF IMPINGEMENT OF THE FEMORAL STEM ON THE UHMWPE ACETABULAR LINER. IMPINGEMENT WAS CONSIDERED LIKELY CAUSE OF DISLOCATION. THIS REPORT FILED ON FEBRUARY 20, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION TOTAL HIP ARTHROPLASTY IN 2002. SUBSEQUENTLY, THE PATIENT'S HIP DISLOCATED AND REVISION PROCEDURE WAS PERFORMED 2008. ACETABULAR LINER AND MODULAR HEAD COMPONENTS WERE REPLACED WITH A CONSTRAINED LINER AND MODULAR HEAD COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ACETABULAR LINER LPH BIOMET, INC. NA 827500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R