BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS RP INSRT SZ 5 7MM

    MDR report key: 9375371 · Received November 26, 2019

    Report

    Report Number
    1818910-2019-117988
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    February 1, 2016
    Report Date
    October 31, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295052449
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    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. OCCUPATION: ATTORNEY. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, TIBIAL LOOSENING AND SUBSIDENCE. THE LOOSENING INTERFACE IS UNKNOWN. DEPUY CEMENT WAS USED. UPDATE 12/08/2016 LITIGATION RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. COMPLAINT WAS UPDATED 12/014/2016. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED SOME LYSIS POSTERIORLY IN THE KNEE AS WELL AS DEBRIDING POSTERIOR SCARRING AND FIBROUS TISSUE AROUND THE FEMUR. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170334 ATTUNE PS RP INSRT SZ 5 7MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 1516-50-507 3600553 10603295052449

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention