BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 4093696 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28214
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    December 27, 2011
    Report Date
    March 28, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. THE PATIENT WAS REVISED ON (B)(6) 2011 FOR A LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573485 PINN CAN BONE SCREW 6.5MMX25MM HIP OTHER IMPLANT: SCREW NDJ 3006356043 JOHNSON & JOHNSON MEDICAL D00454318

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention