BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FB INSRT SZ 7 10MM

    MDR report key: 13110795 · Received December 29, 2021

    Report

    Report Number
    1818910-2021-28946
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    October 6, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295045922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL 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). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    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 · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO PAIN AND LIGAMENTOUS LAXITY WITH HYPEREXTENSION. TIBIAL INSERT WAS EXCHANGED TO A 12MM INSERT.

    Description of Event or Problem · 0

    CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: TIBIAL INSERT REVISED. PRODUCT DETAILS: CATALOG: 150400207 , LOT: 9088539, DESCRIPTION: ATTUNE C/RET FEM RT SZ 7 CEMENTED. CATALOG: 151820041 , LOT: 9084681, DESCRIPTION: ATTUNE MEDIAL DOME PAT 41MM. CATALOG: 150670007 , LOT: 8960194 , DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 7. CATALOG: 151620710 , LOT: J02N42, DESCRIPTION: ATTUNE CR/FB INSERT SZ 7 10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011841 ATTUNE CR FB INSRT SZ 7 10MM ATTUNE IMPLANT : KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 1516-20-710 J02N42 10603295045922

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown Required Intervention ATTUNE CR FEM RT SZ 7 CEM| ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 41MM