BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAT CLAW CONNECTOR 45/55MM

    MDR report key: 3234125 · Received July 18, 2013

    Report

    Report Number
    0001825034-2013-02741
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    November 19, 2003
    Report Date
    June 19, 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
    OH, 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 WARNINGS IT STATES: "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THIS PATIENT (REFERENCE 1825034-2013-02740 / 02742).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE (B)(4) STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. IN REVIEW OF MEDICAL RECORDS, IT WAS IDENTIFIED THE PATIENT HAD PREVIOUSLY UNDERGONE A RECON NAIL PROCEDURE ON (B)(6) 2002 FOR UNKNOWN REASON. SUBSEQUENTLY, IT WAS REPORTED PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2003 TO REMOVED THE DISPLACED TROCHANTERIC CLAW AND CONNECTOR. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336324 LAT CLAW CONNECTOR 45/55MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 933170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R