BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR RP INSRT SZ 7 8MM

    MDR report key: 11213039 · Received January 22, 2021

    Report

    Report Number
    1818910-2021-01642
    Event Type
    Injury
    Date Received
    January 22, 2021
    Date of Event
    January 4, 2021
    Report Date
    January 13, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295048015
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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.

    Description of Event or Problem · 1

    SUBJECT ID: (B)(6). STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). REVISION OF FEMORAL, TIBIAL AND INSERT COMPONENTS. FEMORAL COMPONENT: PRODUCT: 150401207, LOT: 9287085. INSERT COMPONENT: PRODUCT: 151630708, LOT: 9263016. TIBIAL COMPONENT: PRODUCT: 150611006, LOT: 9141123.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112142 ATTUNE CR RP INSRT SZ 7 8MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 1516-30-708 9263016 10603295048015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ATTUNE CR RP INSRT SZ 7 8MM| ATTUNE FEM POR CR RT SZ 7| ATTUNE RP TIB BASE SZ 6 POR| ATTUNE CR RP INSRT SZ 7 8MM| ATTUNE FEM POR CR RT SZ 7| ATTUNE RP TIB BASE SZ 6 POR