BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PFC LINER

    MDR report key: 1020291 · Received March 25, 2008

    Report

    Report Number
    1818910-2008-00971
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM
    Product Code
    KWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND LOT CODE WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR OF THE LINER (LEFT SIDE). HEAD HAD WORN THROUGH TO THE METAL RING IN THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PFC LINER TOTAL HIP PROSTHESIS KWB DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention