BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG POSTLIP INSERT SZ3 8MM

    MDR report key: 2113354 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08950
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED TIBIAL INSERT REVEALED ANTICIPATED WEAR FOR A POLYETHYLENE KNEE DEVICE IMPLANTED FOR APPROXIMATELY FOURTEEN YEARS. THE INVESTIGATION DID NOT FIND ANY EVIDENCE INDICATING PRODUCT FAILURE OR PRODUCT ERROR AS A CONTRIBUTING FACTOR TO THE REPORTED PATIENT PAIN. NO CONCLUSIONS COULD BE DRAWN ABOUT THE ROOT CAUSE OF THE PATIENT PAIN. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

    PATIENT REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG POSTLIP INSERT SZ3 8MM 87 JWH JWH DEPUY ORTHOPAEDICS, INC. NA 07368A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention