BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS PW IM HOLE LOCATOR

    MDR report key: 2134040 · Received June 15, 2011

    Report

    Report Number
    1818910-2011-08527
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT WAS UNABLE TO CONFIRM THE REPORTED EVENT. PREVIOUS INVESTIGATIONS CONDUCTED BY (B)(4) FOR THE SAME PRODUCT AND LOT CODE FOR THE SAME FAILURE MODE CONCLUDED: A REPORT WAS RECEIVED FROM (B)(4), CONCLUDING THERE ARE NO OBVIOUS ENGINEERING DEFECTS WITH THIS INSTRUMENT. IT IS SUSPECTED THAT THE SURGEON MAY HAVE IMPACTED THE BUSHING MORE AGGRESSIVELY THAT INDICATED IN THE SURGICAL TECHNIQUE. BASED ON THE AGE AND CONDITION OF THE RETURNED SAMPLE IT IS REASONABLE TO CONCLUDE THERE ARE NO MANUFACTURING RELATED ISSUES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT: HOWEVER, IT IS SUSPECTED THAT THE SURGEON MAY HAVE IMPACTED THE BUSHING MORE AGGRESSIVELY THAT INDICATED IN THE SURGICAL TECHNIQUE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    FEMORAL FRACTURE OCCURRED VERTICALLY WHEN THE DEVICE WAS HAMMERED IN THE INTERCONDYLAR FOSSA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH CEMENTLESS IMPLANTS AND INTERNAL FIXATION WAS DONE BY CCG BAND (PLUS ORTHOPEDICS). THE SURGERY PROLONGED 180 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS PW IM HOLE LOCATOR 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA A0906

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention