BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA TC3 INS 20MM, SZ 3

    MDR report key: 1518107 · Received October 21, 2009

    Report

    Report Number
    1818910-2009-05793
    Event Type
    Injury
    Date Received
    October 21, 2009
    Date of Event
    September 23, 2009
    Report Date
    September 23, 2009
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT AND PRODUCT PACKAGING WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. THE RECORD REVIEW INCLUDED A COPY OF THE PACKAGING LABEL APPLIED TO THE PACKAGING PRIOR TO DISTRIBUTION. THE LABEL STATES THE PRODUCT WAS A PRODUCT CODE 960534 PFC SIGMA TCS INS 20MM, SZ 3. THE ROOT CAUSE IS BEING ATTRIBUTED TO SUSPECTED USER ERROR. THE INVESTIGATION DID NOT FIND ANY EVIDENCE 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.

    Description of Event or Problem · 1

    PT WAS REVISED BECAUSE, THE INCORRECT DEVICE WAS IMPLANTED DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA TC3 INS 20MM, SZ 3 87JWH JWH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA 265534A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention