BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 20704920 · Received November 18, 2024

    Report

    Report Number
    1818910-2024-23942
    Event Type
    Injury
    Date Received
    November 18, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Product Problem
    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 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿(B)(6) 2016: PATIENT UNDERWENT A LEFT TKA DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS USED. THERE WERE NO COMPLICATIONS NOTED. (B)(6) 2021: PATIENT UNDERWENT A REVISION OF THE LEFT TKA DUE TO FAILED KNEE. THE TIBIAL COMPONENT WAS NOTED TO LOOSEN AND WAS REMOVED FROM THE CEMENT VERY EASILY. THE FEMORAL COMPONENT, PATELLA, AND INSERT WERE ALSO REVISED, BUT THERE WERE NO ALLEGATIONS REPORTED AGAINST THOSE PRODUCTS. COMPETITOR IMPLANTS AND CEMENT WERE PLACED AT REVISION." PRODUCT CODE: 3122040 LOT: 8223862 MANUFACTURING DATE: 26 NOV 2015 EXPIRY DATE: 31 OCT 2017 QUANTITY: 1324 TESTING COULD NOT BE COMPLETED AS THE RETAINED SAMPLES ARE NO LONGER AVAILABLE FOR TESTING. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH. ALL QC AND MICROBIOLOGY TESTING MET RELEASE SPECIFICATION (MS-037 SMARTSET MV BONE CEMENT). 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 PRODUCT CODE: 3122040 LOT: 8223862 MANUFACTURING DATE: 26 NOV 2015 EXPIRY DATE: 31 OCT 2017 QUANTITY: 1324 DEVICE HISTORY REVIEW ==> THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH.

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT TKA DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS USED. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF THE LEFT TKA DUE TO FAILED KNEE. THE TIBIAL COMPONENT WAS NOTED TO LOOSE AND WAS REMOVED FROM THE CEMENT VERY EASILY. THE FEMORAL COMPONENT, PATELLA, AND INSERT WERE ALSO REVISED, BUT THERE WERE NO ALLEGATIONS REPORTED AGAINST THOSE PRODUCTS. COMPETITOR IMPLANTS AND CEMENT WERE PLACED AT REVISION. DOI: ON (B)(6) 2016. DOR: ON (B)(6) 2021. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090748 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY IRELAND - 3015516266 8223862 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention