BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 3080664 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-16127
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    June 7, 2011
    Report Date
    March 28, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 1826218, ZK2EH1000, AR2SF4000 AND BP8CE4000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2445836, 2380416, AR2SF4000, B1WBB4000 AND BK2NJ4000 SINCE ITS SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS AND MEDICAL RECORDS RECEIVED. OPERATIVE NOTES INDICATE A FAILED TOTAL HIP ARTHROPLASTY AND UPON REVISION, SEVERAL BROKEN SCREWS WERE DISCOVERED.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182551 PINN CAN BONE SCREW 6.5MMX35MM SCREW NDJ DEPUY ORTHOPAEDICS INC US BP8CE4000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention