BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/R NPOR FE RT SZ2.5

    MDR report key: 1021312 · Received March 27, 2008

    Report

    Report Number
    1818910-2008-01001
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOTS. PROVIDED INFO INDICATED THAT THE PRODUCTS WERE NOT SUSPECTED OF FAILING TO MEET SPECS OR CONTRIBUTING TO THE EVENT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN. IN ADDITION, NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR TO THE REPORTED IMPLANTATION OF AN EXPIRED PRODUCT. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/R NPOR FE RT SZ2.5 87JWH JWH DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2207526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention