BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PLI XLK INS 2.5 8MM

    MDR report key: 1842509 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06535
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K040166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA PLI XLK INS 2.5 8MM 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2990624

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention