BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV ENDURANCE 80G

    MDR report key: 5778589 · Received July 8, 2016

    Report

    Report Number
    1818910-2016-22799
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 27, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    P960001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED PREVIOUSLY ON LEGACY COMPLAINT COM-203211 DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER.

    Additional Manufacturer Narrative · 0

    PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE MEDICAL DEVICE REMOVAL. 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.

    Description of Event or Problem · 0

    MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 21 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2013, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 1. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT HAD SUBSIDED AND WAS EXTREMELY LOOSE AT THE TIBIAL TRAY/CEMENT INTERFACE. HE NOTED OFFERED NO CONCERNS REGARDING THE FEMORAL NOR PATELLAR COMPONENTS, AND THEY WERE NOT REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH ATTUNE TIBIAL COMPONENT AND SMARTSET BONE CEMENT X 2. DOI: (B)(6) 2013 DOR: (B)(6) 2016 (RT KNEE).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE, INSTABILITY AND LOOSENING AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433521 SMARTSET MV ENDURANCE 80G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 3623610

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FB INSRT SZ 8 5MM| ATTUNE PS FEM RT SZ 8 CEM