BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FEM LT SZ 7 CEM

    MDR report key: 15443184 · Received September 17, 2022

    Report

    Report Number
    1818910-2022-18148
    Event Type
    Injury
    Date Received
    September 17, 2022
    Date of Event
    November 8, 2021
    Report Date
    September 17, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041085
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 DHR REVIEW FOR PRODUCT CODE - 150400107 / LOT - 9030632. 1) QUANTITY MANUFACTURED:12 2) DATE OF MANUFACTURE: 01/19/2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO ANAMOLIES FOUND 4) EXPIRY DATE: 31/12/2028. 5) IFU REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5, D10 (CONCOMITANT). CORRECTED: D2B, D4 (PRIMARY UDI NUMBER). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR LOW GRADE INFECT OF THE LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: IRRIGATION & DEBRIDEMENT WITH REVISION INSERT EXCHANGE ON (B)(6) 2021. REVISION WAS COMPLETED ON (B)(6) 2021 AS TREATMENT FOR THE WORSENING OF THE ORIGINAL INFECTION. CLINICAL DATABASE SPECIFIES FEMORAL STEM, TIBIAL INSERT, TIBIAL BASE, TIBIAL STEM, AND TIBIAL SLEEVE WERE REMOVED. ALL THE PRIMARY IMPLANTS WILL BE CODED FOR INFECTION. THE NEWLY REVISED INSERT WILL NOT BE CODED AS INFECTION AS IT IS NOT LIKELY TO HAVE CONTRIBUTED TO THE ORIGINAL INFECTION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567676 ATTUNE CR FEM LT SZ 7 CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 1504-00-107 9030632 10603295041085

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention ATTUNE CR RP INSRT SZ 7 5MM| ATTUNE CR RP INSRT SZ 7 5MM| ATUN TIB SLV M/L 37MM HALF POR| ATUN TIB SLV M/L 37MM HALF POR| ATUNE PRESSFIT STR STEM16X60MM| ATUNE PRESSFIT STR STEM16X60MM| ATUNE REV RP TIB BASE SZ 5 CEM| ATUNE REV RP TIB BASE SZ 5 CEM| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| UNK ATTUNE KNEE TIBIAL INSERT| UNK ATTUNE KNEE TIBIAL INSERT