BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS RP INSRT SZ 6 8MM

    MDR report key: 10290167 · Received July 17, 2020

    Report

    Report Number
    1818910-2020-16139
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295052593
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INFECTION. SURGEON DID IRRIGATION AND DEBRIDEMENT. SURGEON RETAINED FOLLOWING COMPONENTS: 1504-10-226 L J70K50 AND 1506-80-005 L - 9264999. POLY EXCHANGE WAS DONE. DOI: (B)(6) 2020; DOR: (B)(6) 2020 RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755543 ATTUNE PS RP INSRT SZ 6 8MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 1516-50-608 9198119 10603295052593

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ATTUNE PS FEM RT SZ 6 NAR CEM| ATTUNE RP TIB BASE SZ 5 CEM