BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SCREW

    MDR report key: 3900628 · Received June 27, 2014

    Report

    Report Number
    1818910-2014-22261
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. REPORT ALSO NOTES THAT BROKEN SCREWS WERE REMOVED. FURTHER COMMUNICATION WITH THE REP HAS INDICATED THAT THERE WAS AN ADDITIONAL SCREW THAT WAS LEFT IN THE PATIENT. DOI: UNKNOWN - DOR: (B)(6) 2014 (RIGHT HIP). 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

    PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. REPORT ALSO NOTES THAT BROKEN SCREWS WERE REMOVED. FURTHER COMMUNICATION WITH THE REP HAS INDICATED THAT THERE WAS AN ADDITIONAL SCREW THAT WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377964 UNKNOWN DEPUY SCREW HIP OTHER IMPLANT HWC DEPUY ORTHOPAEDICS, INC.-1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention