BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STAB INS SZ4 8MM

    MDR report key: 2071386 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-06108
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVALUATED BY MANUFACTURER. 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 WITHOUT THE PRODUCT TO EXAMINE. 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

    PT REVISED FOR PAIN AND LOOSE TIBIAL TRAY AT CEMENT/IMPLANT INTERFACE, POLYETHYLENE WEAR WAS NOTED ON INSERT. CEMENT MFG BY OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STAB INS SZ4 8MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 45248A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention