BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. 32MM HEAD +5MM

    MDR report key: 1212628 · Received October 24, 2008

    Report

    Report Number
    1818910-2008-04916
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWY
    PMA / PMN Number
    K893872
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODES REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. 32MM HEAD +5MM 87KWY KWY DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention