BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS RP INSRT SZ 7 10MM

    MDR report key: 21584536 · Received March 12, 2025

    Report

    Report Number
    1818910-2025-03804
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 17, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295052746
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    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 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 RECORDS EVALUATION (MRE) WAS NOT PERFORM 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. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. H11 ADDITIONAL NARRATIVE: ADDED: B5 AND D10.

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: 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 STATES THAT THERE IS CURRENTLY NO REPORTED KNEE RP TIBIAL TRAY COMPONENT. THE INSERT COMPONENT PRODUCT NUMBER: 151650710 ATTUNE PS RP INSRT SZ 7 10MM LOT CODE: 9800690 REQUIRES A KNEE TIBIAL TRAY COMPONENT TO ARTICULATE WITH AT THE RP POST LEVEL. THERE AS NO TIBIA TRAY IN THE PATIENT. THIS PATIENT HAD A SPACER IN AND IT WAS FULLY REMOVED AND THEY DID NOT PUT ANYTHING BACK INTO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DISLOCATED HER ANTIBIOTIC SPACER AND GETS CHRONIC INFECTIONS. DOCTORS REMOVED ALL IMPLANTS AND CEMENTED IN AN XFIX. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229690 ATTUNE PS RP INSRT SZ 7 10MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 9800690 10603295052746

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention ATTUNE DIST FEM AUG SZ 7 16MM| DEPUY CMW 2 20G| DEPUY CMW 2 20G| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO