BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 3926429 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23110
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 29, 2013
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. QUANTITY:4. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. THERE IS LITIGATION INVOLVING THIS PATIENT. FOLLOW-UP ACTIVITIES ARE BEING PERFORMED BY THE DEPUY LEGAL TEAM. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORTING STATES IT CONTAINS ALL INFORMATION PRESENTLY AVAILABLE. THERE IS LITIGATION INVOLVING THIS PATIENT. FOLLOW-UP ACTIVITIES ARE BEING PERFORMED BY THE DEPUY LEGAL TEAM. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MAUDE REPORT (B)(4) SUBMITTED BY A PATIENT STATES THAT S/HE HAS EXPERIENCED PAIN, SWELLING, WARMTH IN LEFT KNEE, SEVERE CLICKING, INABILITY TO BEAR WEIGHT FOR OVER 5 MINUTES OR GO UP AND DOWN ONE STEP WITHOUT ASSISTANCE. LEG LENGTH DISCREPANCY, URINARY INCONTINENCE, WORSENING OF MIGRAINES WAS ALSO REPORTED. PAIN IN ARMS, NECK, AND TRAPEZIUS AREA HAS DEVELOPED DUE TO INABILITY TO USE KNEES. UPDATE RECEIVED (B)(6) 2013 - THE COMPLAINT HAS BEEN REOPENED IN ORDER FOR IT TO BE UPDATED, AS A DUPLICATE REPORT (B)(4) HAS BEEN DISCOVERED. THERE IS NO NEW INFORMATION THAT WILL AFFECT THE EXISTING MDR DECISION. THIS COMPLAINT WAS UPDATED (B)(6) 2013. UPDATE - (B)(6). UPDATE REC'D (B)(6) 2014- MAUDE REPORT RECEIVED, (B)(4). MAUDE REPORT INDICATES THAT THE PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2014, FOR TIBIAL TRAY LOOSENING AT THE CEMENT/IMPLANT INTERFACE. WE ARE UNAWARE OF WHICH TIBIAL TRAY WAS LOOSE; THEREFORE, WE CHOSE ONE. THE TIBIAL TRAY AND CEMENT HAVE BEEN REPORTED. ADDITIONALLY, THE PATIENT ALLEGES HEART ISSUES AND PAIN IN HER ARM. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE THE COMPLAINT ACCORDINGLY. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403996 SMARTSET GHV GENTAMICIN 40G PRODUCTS AND CEMENT ACCESSORIES LOD DEPUY CMW 9610921 3350084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention