BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX15MM

    MDR report key: 2925585 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-02213
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    April 14, 2009
    Report Date
    December 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT. UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF INFECTION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    PPF HAS NO NEW ALLEGATION REPORTED. ADDED LAWYER, REVISION SURGEON, HOSPITAL, AGE, MANUFACTURED AND EXPIRATION DATE OF IPS. DOI: (B)(6)2009 - DOR (B)(6)2009 (RIGHT HIP)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29483 PINN CAN BONE SCREW 6.5MMX15MM BONE SCREWS AND PINS : SCREWS LPH DEPUY ORTHOPAEDICS INC US CA8AD4000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention