BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX15MM

    MDR report key: 3163070 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18627
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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

    EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST PRODUCT ERROR. IN ONE AREA ON THE REVISED CUP THERE IS EVIDENCE OF BONEY ON-GROWTH HAVING OCCURRED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. A REPORT FROM THE HOSPITAL PATHOLOGY DEPARTMENT AND REVISION OPERATIVE NOTE WAS PROVIDED. NO CONCLUSIONS COULD BE DRAWN FROM THE DEVICE EXAMINATION OR REVIEW OF THE PROVIDED RECORDS. A ROOT CAUSE WAS NOT IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    H10 ADDITIONAL NARRATIVE: ADDITIONAL INFO: F10 THIS COMPLAINT IS STILL CONSIDERED CLOSED.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 INVESTIGATION REMAINS CLOSED, AS THE ADDED INFORMATION DOES NOT CHANGE THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP. METALLOSIS WAS ALSO REPORTED. UPDATE: (B)(4) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION 2 OF 3 SCREWS WERE REMOVED DUE TO CUP LOOSENING. 1 SCREW WAS STRIPPED AND HAD TO BE LEFT IN PLACE. 3 SCREWS ARE BEING ADDED TO THE COMPLAINT FOR CUP LOOSENING.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263582 PINN CAN BONE SCREW 6.5MMX15MM SCREW NDJ DEPUY ORTHOPAEDICS INC US B4TAY4000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention