BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 3 CEM

    MDR report key: 11596632 · Received March 31, 2021

    Report

    Report Number
    1818910-2021-06660
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 15, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042570
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE RECEIVED DEVICE WAS FORWARDED TO COMMERCIALIZED PRODUCT DEVELOPMENT FOR EVALUATION. REVIEW OF THE RECEIVED DEVICE CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED .

    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. H10 ADDITIONAL NARRATIVE:  ADDED: D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H3.

    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

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON REVISED THE TIBIA TO AN ATTUNE REVISION FB TIBIA (1506003/9053338) WITH A CEMENTED STEM (151214080/J46J98) AND PS FB INSERT (151640508/J74J87). THESE WAS NO INFORMATION OF THE LOT NUMBER OF THE DEPUY CEMENT USED. THE SURGEON STATED THAT THERE HAS BEEN DOCUMENTED FAILURES WITH THIS ATTUNE DEVICE. THE TIBIAL FAILED IN LESS THAN 4 YEARS. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492907 ATTUNE RP TIB BASE SZ 3 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-10-003 8619505 10603295042570

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention ATTUNE PS RP INSRT SZ5 6MM| ATTUNE RP TIB BASE SZ 3 CEM| UNKNOWN BONE CEMENT