BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PLI XLK INS 2 10MM

    MDR report key: 992958 · Received February 7, 2008

    Report

    Report Number
    1818910-2008-00174
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 16, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DE PUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K040166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADD'L REPORTS OF THIS NATURE OF THE PRODUCT CODE/LOT PROVIDED SINCE ITS RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE, BUT NO EVIDENCE WAS FOUND THAT WOULD SUGGEST PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS PAIN. THE KNEE WAS TIGHT IN FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA PLI XLK INS 2 10MM 87JWH JWH DEPUY-CORK, A DIVISION OF DE PUY ORTHOPAEDICS NA 2092173

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention