BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN.SECTOR ACET.CUP 52MM

    MDR report key: 3060201 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-15421
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO CUP MIGRATION.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013: PATIENT HAD PAIN AND MIGRATION WAS CONFIRMED IN X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162515 PINN.SECTOR ACET.CUP 52MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS 305310

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention