BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 5 STD OFFSET

    MDR report key: 1242635 · Received November 20, 2008

    Report

    Report Number
    1818910-2008-05381
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT FELL CAUSING PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR 3 WEEKS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-LOCK BPS SZ 5 STD OFFSET 87KWA KWA DEPUY ORTHOPAEDICS, INC. NA CL4CK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention