BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 4110134 · Received September 23, 2014

    Report

    Report Number
    1818910-2014-28629
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    May 5, 2011
    Report Date
    March 26, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM
    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

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED ON (B)(6) 2011 FOR INFECTION AND LOOSE SCREWS AND CUP. ALL IMPLANTS WERE REMOVED AND SPACERS WERE PLACED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2011. THIS COMPLAINT IS LEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590769 PINN CAN BONE SCREW 6.5MMX20MM HIP OTHER IMPLANT: SCREW NDJ 1219655 DEPUY-RAYNHAM 442060

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention