BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 3932749 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23289
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PATIENT PRESENTED TO THE SURGEON THE CUP APPEARED TO SPIN AND WAS NOW VERTICAL. DURING THE OPERATION THE SURGEON OBSERVED A TRANSVERSE ACETABULAR FRACTURE. THE CUP WAS ALSO NOTICED TO BE LOOSE. DOI: (B)(6) 2014, DOR: (B)(6) 2014 (LEFT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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.

    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.

    Description of Event or Problem · 1

    WHEN THE PATIENT PRESENTED TO THE SURGEON, THE CUP APPEARED TO SPIN AND WAS NOW VERTICAL. DURING THE OPERATION, THE SURGEON OBSERVED A TRANSVERSE ACETABULAR FRACTURE. THE CUP WAS ALSO NOTICED TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409142 PINN CAN BONE SCREW 6.5MMX35MM HIP OTHER IMPLANT NDJ JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 D12113219

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention