BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM LT SZ 6 CEM

    MDR report key: 3953026 · Received July 23, 2014

    Report

    Report Number
    1818910-2014-24077
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    PMA / PMN Number
    PK111433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    MEDICAL NOTES WERE RECEIVED AND TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED FROM BIOENGINEERING STATING THAT THE COMPLAINT IS INCORRECTLY ATTRIBUTED TO THE IMPLANTS AND NOT THE FEMORAL TRIAL ¿ THE FRACTURE OCCURRED DURING IMPACTION OF TRIAL. NO INSTRUMENTS WERE RETURNED FOR ANALYSIS SO THE PARTS COULD NOT BE CHECKED. THE COMPLAINT WAS REPORTED TO BE PROCEDURE RELATED. NO DEVICE DEFECTS WERE REPORTED. NOTIFICATION WAS RECEIVED STATING THE FURTHER INFORMATION WITH REGARD TO THE TRIAL IS NOT AVAILABLE. AS NO PRODUCT AND LOT NUMBERS OF THE TRIAL WERE RECEIVED A COMPLAINT DATABASE SEARCH AND MANUFACTURING REVIEW COULD NOT BE CONDUCTED. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    MEDICAL NOTES WERE RECEIVED AND TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED FROM BIOENGINEERING STATING THAT THE COMPLAINT IS INCORRECTLY ATTRIBUTED TO THE IMPLANTS AND NOT THE FEMORAL TRIAL ¿ THE FRACTURE OCCURRED DURING IMPACTION OF TRIAL. NO INSTRUMENTS WERE RETURNED FOR ANALYSIS SO THE PARTS COULD NOT BE CHECKED. THE COMPLAINT WAS REPORTED TO BE PROCEDURE RELATED. NO DEVICE DEFECTS WERE REPORTED. NOTIFICATION WAS RECEIVED STATING THE FURTHER INFORMATION WITH REGARD TO THE TRIAL IS NOT AVAILABLE. AS NO PRODUCT AND LOT NUMBERS OF THE TRIAL WERE RECEIVED A COMPLAINT DATABASE SEARCH AND MANUFACTURING REVIEW COULD NOT BE CONDUCTED. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. 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

    (B)(4). LATERAL FEMORAL CONDYLE CRACK. FIXED WITH SCREWS DURING SURGERY (B)(6) 2014. PATIENT WILL MOBILISE WITH A HINGED KNEE BRACE FOR SIX WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430814 ATTUNE PS FEM LT SZ 6 CEM KNEE FEMORAL COMPONENT JWH DEPUY ORTHOPAEDICS, INC.1818910 7596065

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention