BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR LINER

    MDR report key: 4192627 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30429
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS IMPLANT BEARING WEAR AND PAIN. THE CUP WAS ALSO NOTED TO BE VERTICAL. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. THE PATIENT WAS IMPLANTED WITH DEPUY DEVICES CIRCA 1995 AND REVISED FOR IMPLANT BEARING WEAR AND A VERTICAL CUP POSITIONING IN (B)(6) 2014. IT IS NOT ABNORMAL TO FIND DEVICE WEAR 19 YEARS POST PRIMARY IMPLANTATION. NO PATIENT X-RAYS WERE PROVIDED AND PRIMARY POSITIONING AND/OR COMPONENT MIGRATION CANNOT BE COMMENTED UPON. THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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. UDI: UNAVAILABLE. SEE SECTION D FOR ANY PRODUCT INFORMATION RECEIVED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS IMPLANT BEARING WEAR AND PAIN. THE CUP WAS ALSO NOTED TO BE VERTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672152 UNKNOWN DEPUY ACETABULAR LINER HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention