BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX40MM

    MDR report key: 4173410 · Received October 15, 2014

    Report

    Report Number
    1818910-2014-29819
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    June 17, 2009
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. IT WAS REPORTED THE PATIENT WAS PRIMARILY IMPLANTED WITH DEPUY DEVICES ON (B)(6) 2008 AND REVISED FOR INFECTION ON (B)(6) 2009. IT IS NOT LIKELY OR REASONABLE TO CONCLUDE THE DEPUY DEVICES CONTRIBUTED TO THE PATIENT'S REPORTED INFECTION ALMOST ONE FULL YEAR POST PRIMARY IMPLANTATION. NO OTHER REPORTS OF INFECTION WERE FOUND AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO 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.

    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. (B)(4).

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT MADE LEGAL. PPD ALLEGES INFECTION. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY THE PATIENT HAD ALL IMPLANTS REMOVED (EXCEPT THE STEM) ON (B)(6) 2009 FOR INFECTION AND SPACERS WERE PLACED. THE STEM WAS MOVED ON (B)(6) 2009 FOR INFECTION, LOOSENING, AND SUBSIDENCE AND PROSTALAC WAS PLACED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653030 PINN CAN BONE SCREW 6.5MMX40MM HIP OTHER IMPLANT: SCREW NDJ DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG. CT6CJ4000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention