BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM SZ1 (JDI)

    MDR report key: 4126220 · Received September 29, 2014

    Report

    Report Number
    1818910-2014-28994
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 23, 2014
    Report Date
    February 12, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK982918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNAVAILABLE. 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

    A REVIEW OF MANUFACTURING RECORDS AND COMPLAINTS DATABASES DID NOT IDENTIFY ANY ANOMALIES. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    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. (B)(4).

    Description of Event or Problem · 1

    BILATERAL CSTEM REVISION DUE TO PAIN AND BONE CEMENT LUCENCIES. SEPTIC LOOSENING SUSPECTED, BUT CULTURES WERE NEGATIVE.

    Description of Event or Problem · 1

    UPDATE: 12-FEB-2015 MEDICAL RECORDS RECIEVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, LOOSE STEM, NO OSTEOLYSIS, AND NO CULTURES WERE TAKEN. ALL IMPLANTS WERE REVISED. THIS COMPLAINT WAS UPDATED ON 3-MAR-2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605936 C-STEM SZ1 (JDI) HIP FEMORAL STEM/SLEEVE JDI DEPUY ORTHOPAEDICS, INC. YHX-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention