BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 2502948 · Received March 25, 2012

    Report

    Report Number
    1818910-2012-07396
    Event Type
    Injury
    Date Received
    March 25, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 29, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 2/23/2012 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS PAIN AND SQUEAKING. THE CUP AND SCREWS WERE ADDED TO THE COMPLAINT. (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 ITS RELEASE FOR DISTRIBUTION. 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 AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    PATIENT CONTACTED DEPUY REQUESTING COMPENSATION. HE CLAIMS HE EXPERIENCED INTERMITTENT SQUEAKING AND CATCHING. MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS PAIN AND SQUEAKING. THE CUP AND SCREWS WERE ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX20MM BONE SCREW NDJ DEPUY RAYNHAM 430921

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention