BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 10/19.5 L LRG STAT

    MDR report key: 2945091 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-11936
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DURING IMPLANTATION, THE BOWED STEM BROKE THROUGH THE CORTEX BECAUSE THE PATIENT HAD VERY LITTLE NATURAL BOW IN HIS FEMUR. THE INCISION HAD TO BE EXTENDED AND CIRCLAGE CABLES USED. A STRAIGHT STEM WAS USED INSTEAD. THIS RESULTED IN A SURGICAL DELAY OF 1 HOUR. (LEFT HIP) THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. MEDICAL RECORDS, INCLUDING X-RAYS WERE RECEIVED. A REVIEW OF THE PROVIDED X-RAY IMAGES AND PATIENT RECORDS DID NOT IDENTIFY A ROOT CAUSE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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

    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

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

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE BOWED STEM BROKE THROUGH THE CORTEX BECAUSE THE PATIENT HAD VERY LITTLE NATURAL BOW IN HIS FEMUR. THE INCISION HAD TO BE EXTENDED AND CIRCLAGE CABLES USED. A STRAIGHT STEM WAS USED INSTEAD. THIS RESULTED IN A SURGICAL DELAY OF 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49922 SOL SYS 10/19.5 L LRG STAT FEMORAL HIP STEM LPH DEPUY ORTHOPAEDICS, INC. 127042

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention