BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 8335548 · Received February 13, 2019

    Report

    Report Number
    1818910-2019-84360
    Event Type
    Injury
    Date Received
    February 13, 2019
    Report Date
    January 22, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE WAS IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER 5082340. INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL ¿ "UNKNOWN REPORTER FROM ANOTHER MANUFACTURER". (B)(4).

    Description of Event or Problem · 1

    MAUDE EVENT REPORT MW 5082340 STATES: REPORTER CALLED FROM ANOTHER MANUFACTURER TO REPORT MAJOR ISSUES WITH DEPUY ATTUNE KNEE REPLACEMENT. REPORTER STATED THAT THEY HAVE SEEN APPROXIMATELY 50 REVISIONS OF THIS SPECIFIC KNEE. WHERE THE BASEPLATE JUST FALLS OUT. REPORTER STATED THAT DEPUY MADE A RUNNING CHANGE TO ADDRESS ISSUES WITH THE DEVICE BUT CONTINUES TO HIDE IT FROM THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130012 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention