BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARDINGE FEM CEMENT RESTR

    MDR report key: 5193699 · Received November 1, 2015

    Report

    Report Number
    1818910-2015-34108
    Event Type
    Injury
    Date Received
    November 1, 2015
    Date of Event
    January 28, 2010
    Report Date
    October 28, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED ON (B)(6) 2010 (B)(4). DURING THE (B)(6) 2010 OPERATION, THE PATIENT CODED AND WENT ASYSTOLE. CPR WAS PERFORMED AND HEART RATE RETURNED. THE SURGEON NOTED THE PATIENT WAS A LITTLE UNSTABLE AND THE PATIENT NEEDED TO GET TO ICU. ALL OF THE PRODUCTS THE SURGEON HAD JUST IMPLANTED ARE NOW BEING REPORTED. THE LINER AND CUP WERE IMPLANTED IN 2002 AND PRODUCTS ARE UNKNOWN. THERE WAS NO INDICATION AS TO WHAT CAUSED THE PATIENT TO GO ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724032 HARDINGE FEM CEMENT RESTR CEMENT / CEMENT ACCESSORY LOD DEPUY ORTHOPAEDICS INC US 2902555

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other