BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX30MM

    MDR report key: 2491749 · Received March 14, 2012

    Report

    Report Number
    1818910-2012-06158
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    DEPUY SUZHOU
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTS THE PATIENT WAS REVISED FOR DISLOCATION, SUSPECTED CUP POSITIONING CAUSED DISLOCATION. DOI: (B)(6) 2011. DOR: (B)(6) 2012 (RIGHT 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 SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. IT WAS REPORTED THAT THE CUP HAD BEEN PLACED WITH MORE VERSION THAN NECESSARY AND THAT IT WAS THE POSITIONING THAT CONTRIBUTED TO THE PATIENT DISLOCATING. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR DISLOCATION, SUSPECTED CUP POSITIONING CAUSED DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX30MM HIP NDJ DEPUY SUZHOU D00456126

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention