BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STAB INS SZ3 8MM

    MDR report key: 2073563 · Received April 26, 2011

    Report

    Report Number
    1818910-2011-07313
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 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
    PA, 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 IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS. THE TIBIAL TRAY WAS ALSO REPORTED TO BE LOOSE AT THE CEMENT/BONE INTERFACE; HOWEVER, THE MANUFACTURER OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STAB INS SZ3 8MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention