BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS HO 17.0

    MDR report key: 3759363 · Received April 18, 2014

    Report

    Report Number
    0001825034-2014-02984
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 20, 2014
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, ¿INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE STEM TO BROACH COMBINATION CAUSED A PROXIMAL FEMUR FRACTURE. THIS SAME SET OF IMPLANTS WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237785 TPRLC 133 TYPE1 PPS HO 17.0 PROSTHESIS, HIP KWA BIOMET U.K. LTD N/A 3225883

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R