BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY1 GENTAMICIN CEMENT 40G

    MDR report key: 5755785 · Received June 28, 2016

    Report

    Report Number
    1818910-2016-22340
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    January 28, 2016
    Report Date
    June 14, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK023103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDED : DESCRIBE EVENT OR PROBLEM; OTHER RELEVANT HISTORY; DATE RECEIVED BY MFG. 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

    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

    ON THE BASIS OF THE RECEIVED COMPONENTS AND MEDICAL RECORDS, AS WELL AS THE DEVICE HISTORY RECORDS, THERE IS NO EVIDENCE OF ANY COMPONENT DEFECT OR DEFICIENCY WHICH COULD HAVE CONTRIBUTED TO THE PATIENT'S REPORTED PAIN, LOOSENING, OR LACK OF EXTENSION. THERE ARE MULTIPLE FACTORS THAT CAN INFLUENCE THE SUCCESS OF A KNEE ARTHROPLASTY. IN THIS CASE, THE PATIENT'S PRE-EXISTING FLEXION CONTRACTURE, OBESITY, REPORTED FALL, AND DEGENERATIVE CHANGES IN HER RIGHT KNEE MAY ALL HAVE CONTRIBUTED TO HER CONCERNS. NO PRODUCT CONTRIBUTION TO THE REPORTED EVENT WAS IDENTIFIED. 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

    PATIENT CORRESPONDENCE: PATIENT STATES THAT THE KNEE WOULD NOT BEND FROM THE TIME SHE CAME HOME FROM THE HOSPITAL. THE KNEE BECAME PAINFUL AND SWOLLEN AND EVENTUALLY LEAD TO BACK PAIN AND HIP PAIN.

    Description of Event or Problem · 1

    UPDATE REC'D 10/28/2016. THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE REC'D 08/22/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. AT THIS TIME THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410543 DEPUY1 GENTAMICIN CEMENT 40G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 3557265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention