BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 5135567 · Received October 8, 2015

    Report

    Report Number
    1818910-2015-32325
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    August 17, 2010
    Report Date
    September 9, 2015
    Manufacturer
    DEPUY CMW ¿ 9610921 
    Product Code
    LOD
    PMA / PMN Number
    PK033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 COMPLAINT DATABASE SEARCH ON THE PROVIDED (B)(4) GENTAMICIN 40G (PRODUCT CODE 545035500, LOT NUMBER 2980992) FOUND ADDITIONAL REPORTS. A PREVIOUS DHR REVIEW (B)(4) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED INCIDENT(S) AGAINST THE REMAINING PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE THE BOLT FAILED AND FRACTURED. UPDATE: 6/21/2011 - RECEIVED STICKER PAGES FROM THE LEGAL DEPARTMENT, WHICH INCLUDES PRODUCT CODE AND LOT INFORMATION. UPDATE: 08/21/2011 - REVISION OPERATIVE REPORT RECEIVED AND STATES DISASSOCIATION BETWEEN THE FEMORAL COMPONENT AND THE FEMORAL STEM, AS WELL AS THE BOLT CONNECTING THE TWO HAD BROKEN; THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND WITH SUCH DISASSOCIATED FROM THE FEMORAL STEM. FEMORAL STEM AND FEMORAL COMPONENT ADDED TO COMPLAINT. DOR: (B)(6) 2010. UPDATE: 9/9/2015 - MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE CEMENT IS NOW BEING ADDED FOR THE GROSSLY LOOSE STEM. PAIN WAS ALSO INDICATED IN THE REVISION OPERATIVE NOTE. THE MEDICAL RECORDS ALSO INDICATE THERE WAS A PREVIOUS NON-HEALING FRACTURE OF THE UPPER FEMUR THAT WAS CABLED, THE DATE AND CAUSE OF THE FRACTURE IS UNKNOWN AT THIS TIME. THE COMPLAINT WAS UPDATED ON: 10/7/2015.

    Description of Event or Problem · 1

    UPDATE 2/29/2016 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: MAR 15, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666948 SMARTSET GHV GENTAMICIN 40G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW ¿ 9610921  2980992

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention