BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC BANTAM ACET CUP 38 OD

    MDR report key: 3926067 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23105
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    LPH
    PMA / PMN Number
    PK961186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS LEADING TO PELVIC BONE DETERIORATION. LOOSENING OF THE CUP WAS ALSO NOTED. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A DHR REVIEW OR LOT SPECIFIC DATABASE SEARCH WAS NOT POSSIBLE FOR THE ADDITIONAL PRODUCT ASSOCIATED WITH THIS REPORT AS LOT CODE(S) WAS NOT PROVIDED. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS LEADING TO PELVIC BONE DETERIORATION. LOOSENING OF THE CUP WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403368 DURALOC BANTAM ACET CUP 38 OD HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC.-1818910 T5VBT1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention