BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG MOD TIB TRAY CEM SZ2.5

    MDR report key: 1931382 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-09087
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE REVEALED EVIDENCE SUGGESTING LOOSENING WHILE IN VIVO. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING. 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 ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS LOOSENING OF THE CEMENT/IMPLANT INTERFACE. THE MANUFACTURER OF THE CEMENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG MOD TIB TRAY CEM SZ2.5 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1054860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention