BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 1 HI OFFSET

    MDR report key: 3406410 · Received October 11, 2013

    Report

    Report Number
    1818910-2013-30260
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    September 24, 2013
    Report Date
    September 24, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. BROACHED FOR A SIZE 1 TRI-LOCK STEM. IMPLANTED SIZE 1 HI TRI-LOCK, WHICH SAT UP 2CM AND FRACTURED THE PATIENT'S FEMUR. SURGEON PUT CABLES ON, THEN PUT ANOTHER SIZE 1 HI TRI-LOCK STEM IN, AND COMPLAINED THAT, TOO, SAT UP. RELATED DIMENSIONAL INSPECTION OF THE RETURNED STEM AND BROACH FINDS NO DISCREPANCY FROM REQUIREMENTS THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR BOTH THE RETURNED AND IMPLANTED TRI-LOCK STEM LOTS 212856 AND 206151. NO RELATED DEVIATIONS OR ANOMALIES WERE IDENTIFIED. SURGEON TECHNIQUE IS SUSPECTED TO BE A FACTOR IN THE PROBLEMS EXPERIENCED. BASED ON THE INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. BROACHED FOR A SIZE 1 TRI-LOCK STEM. IMPLANTED SIZE 1 HI TRI-LOCK, WHICH SAT UP 2CM AND FRACTURED THE PATIENT'S FEMUR. SURGEON PUT CABLES ON, THEN PUT ANOTHER SIZE 1 HI TRI-LOCK STEM IN, AND COMPLAINED THAT, TOO, SAT UP. RELATED DIMENSIONAL INSPECTION OF THE RETURNED STEM AND BROACH FINDS NO DISCREPANCY FROM REQUIREMENTS THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR BOTH THE RETURNED AND IMPLANTED TRI-LOCK STEM LOTS 212856 AND 206151. NO RELATED DEVIATIONS OR ANOMALIES WERE IDENTIFIED. SURGEON TECHNIQUE IS SUSPECTED TO BE A FACTOR IN THE PROBLEMS EXPERIENCED. BASED ON THE INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    BROACHED FOR A SIZE 1 TRI-LOCK STEM. IMPLANTED SIZE 1 HI TRI-LOCK, WHICH SAT UP 2CM AND FRACTURED THE PATIENT'S FEMUR. SURGEON PUT CABLES ON, THEN PUT ANOTHER SIZE 1 HI TRI-LOCK STEM IN, AND COMPLAINED THAT, TOO, SAT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521712 TRI-LOCK BPS SZ 1 HI OFFSET FEMORAL HIP STEM KWA 1818910 DEPUY ORTHOPAEDICS, INC. 212856

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention