BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MULTIHOLE W/GRIPTION 48MM

    MDR report key: 1842515 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06452
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY PREVIOUS REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS. REVIEW OF THE DEVICE HISTORY RECORDS/STERILIZATION CERTIFICATIONS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MULTIHOLE W/GRIPTION 48MM 87KWA; 87LZO KWA DEPUY ORTHOPAEDICS, INC. NA C2SFG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention