BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERAL CLAW CONNECTOR 45/55MM

    MDR report key: 3212291 · Received July 9, 2013

    Report

    Report Number
    0001825034-2013-02545
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK031693
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT THE DEVICE DISLOCATED AS A RESULT OF THE IMPLANTS NOT BEING COMPLETELY THREADED UPON IMPLANTATION.

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2013, DUE TO LOOSENING OF THE CALCAR CLAW. THE CONNECTOR AND BOLT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312973 LATERAL CLAW CONNECTOR 45/55MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 513200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R