BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE TIBIAL INSERT

    MDR report key: 19538924 · Received June 14, 2024

    Report

    Report Number
    1818910-2024-12941
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 14, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    CORRECT DATA: E1, INITIAL REPORTER COUNTRY CODE: CAN.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MANIAR AR, MACDONALD SJ. SECONDARY PATELLAR RESURFACING FOLLOWING PRIMARY UNRESURFACED TOTAL KNEE ARTHROPLASTY: BEWARE OF THE INCIDENCE OF LATE PATELLAR EROSION. J ARTHROPLASTY. 2024 APR 15:S0883-5403(24)00334-6. DOI: 10.1016/J.ARTH.2024.04.022. EPUB AHEAD OF PRINT. PMID: 38621428. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MANIAR AR, MACDONALD SJ. SECONDARY PATELLAR RESURFACING FOLLOWING PRIMARY UNRESURFACED TOTAL KNEE ARTHROPLASTY: BEWARE OF THE INCIDENCE OF LATE PATELLAR EROSION. J ARTHROPLASTY. 2024 APR 15:S0883-5403(24)00334-6. DOI: 10.1016/J.ARTH.2024.04.022. EPUB AHEAD OF PRINT. PMID: 38621428. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY AIM OF THIS STUDY WAS TO EVALUATE SECONDARY PATELLAR RESURFACING (SPR) INDICATIONS AND RATES UTILIZING THE DEPUY ATTUNE CEMENTED TKA IMPLANTED BETWEEN 01 JANUARY 2013 AND 31 DECEMBER 2021 AND ADDITIONALLY, TO REVIEW THE FUNCTIONAL OUTCOMES OF PATIENTS AFTER UNDERGOING SPR. THERE WERE 406 PATIENTS WHO RECEIVED RESURFACED PATELLAS AT PRIMARY IMPLANTATION AND 1,105 PATIENTS WHOSE PATELLAS WERE NOT RESURFACED. THE MANUFACTURER OF THE CEMENT USED IS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN ATTUNE FEMORAL COMPONENT, UNK ATTUNE TIBIAL TRAY, UNK ATTUNE TIBIAL INSERT, UNK ATTUNE PATELLA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE FEMORAL COMPONENT (QTY 23): 17 INFECTIONS TREATED WITH REVISION. 4 REVISIONS TO TREAT LOOSENING OF THE FEMORAL COMPONENT AT AN UNKNOWN INTERFACE. 1 REVISION TO TREAT STIFFNESS. 1 REVISION TO TREAT INSTABILITY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE TIBIAL TRAY (QTY 23). 17 INFECTIONS TREATED WITH REVISION. 4 REVISIONS TO TREAT LOOSENING OF THE TIBIAL TRAY AT AN UNKNOWN INTERFACE. 1 REVISION TO TREAT STIFFNESS. 1 REVISION TO TREAT INSTABILITY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE TIBIAL INSERT (QTY 19). 17 INFECTIONS TREATED WITH REVISION. 1 REVISION TO TREAT STIFFNESS. 1 REVISION TO TREAT INSTABILITY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE. PATELLA (QTY 5): 3 INFECTIONS TREATED WITH REVISION. 2 REVISIONS TO TREAT LOOSENING OF THE PATELLA AT AN UNKNOWN INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389932 UNK ATTUNE KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention