BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX90/RINGLOC 10DEG CONST 44X32

    MDR report key: 3041956 · Received April 9, 2013

    Report

    Report Number
    0001825034-2013-00888
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. BIOMET PACKAGE INSERT CONTAINS THE FOLLOWING POSSIBLE ADVERSE EFFECTS: 8. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00887 / 00890).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, REVIEW OF INVOICE HISTORY SHOWS THE PATIENT WAS REVISED (B)(6) 2003, (B)(6) 2010, AND (B)(6) 2011, ALL FOR UNKNOWN REASONS. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2013 DUE TO DISASSOCIATION OF THE ACETABULAR LINER FROM THE CUP. THE MODULAR HEAD, ACETABULAR LINER AND LOCKING RING COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145720 RX90/RINGLOC 10DEG CONST 44X32 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 429780

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R