BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STB INS S2.5 22.5MM

    MDR report key: 1031817 · Received April 17, 2008

    Report

    Report Number
    1818910-2008-01423
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY -RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN OR POLYETHYLENE WEAR LOOSENING BASED ON THE PROVIDED INFO. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN. POLY WEAR WAS NOTED ON THE BACKSIDE OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STB INS S2.5 22.5MM 87JWH JWH DEPUY ORTHOPAEDICS, INC., DEPUY -RAYNHAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention