BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 7 CEM

    MDR report key: 11582165 · Received March 29, 2021

    Report

    Report Number
    1818910-2021-06321
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 18, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295492092
    PMA / PMN Number
    K170806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE DID NOT FIND ANY EVIDENCE OF PRODUCT MALFUNCTION OR PRODUCT ERROR. 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. DEVICE HISTORY LOT: THE DEVICE HISTORY RECORDS (DHR) FOR THE ATTUNE TIBIAL BASE FIXED BEARING, SIZE 7, CEMENTED (P/N 1506-70-007, LOT # 9249802) WERE REVIEWED. NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES WERE IDENTIFIED.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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. INVESTIGATION SUMMARY: UPDATE 27-JAN-2021: THE INVESTIGATION WAS RE-OPENED UPON RECEIPT OF ADDITIONAL INFORMATION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SUBJECT KNEE REPLACEMENT (B)(6) 2019. FROM (B)(6) 2020 TO (B)(6) 2020 HE EXPERIENCED PAIN, INSTABILITY, EDEMA, WALKING DIFFICULTY, AND STIFFNESS. HIS LEG GAVE OUT SEVERAL TIMES AND HE HEARD A CLUNKING NOISE WHEN WALKING. PATIENT WAS REVISED ON (B)(6) 2021. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477980 ATTUNE FB TIB BASE SZ 7 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 1506-70-007 9249802 10603295492092

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FB INSRT SZ 6 6MM| ATTUNE PS FEM RT SZ 6 CEM| SMARTSET HV BONE CEMENT 40G| SMARTSET MV 40G - EO| ATTUNE FB TIB BASE SZ 7 CEM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FB INSRT SZ 6 6MM| ATTUNE PS FEM RT SZ 6 CEM| SMARTSET HV BONE CEMENT 40G| SMARTSET MV 40G - EO