BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC STB 10MM SZ4

    MDR report key: 1864441 · Received October 6, 2010

    Report

    Report Number
    1818910-2010-07245
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K882234
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT LOT CODE REQUIRED TO SEARCH THE COMPLAINT DATABASE BY MANUFACTURING LOT CODE WAS NOT SUPPLIED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. BASED ON THE PERFORMED INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROXIMATELY 14-1/2 YEARS PRIOR TO REVISION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING THE LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE TIBIAL INSERT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE NEWLY PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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

    PT WAS REVISED TO ADDRESS POLY WEAR RESULTING IN METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC STB 10MM SZ4 87 JWH JWH DEPUY RAYNHAM NA 53S1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention