BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 9410205 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-120144
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    June 17, 2019
    Report Date
    October 28, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K023012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. DEVICE HISTORY LOT: 8151376. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: A PREVIOUS DHR (DEVICE HISTORY RECORD) REVIEW (B)(4)) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (8151376). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (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

    ON (B)(6) 2015, 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 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, CHROME COBALT, QUESTIONABLE METAL ALLERGY OR SENSITIVITY, AND PAIN. THE SURGEON REPORTED SYNOVIAL SAMPLES RETURNED NEGATIVE FOR ACUTE INFLAMMATION AND THERE WAS NO EVIDENCE OF INFECTION. HE REPORTED MILD ARTHROFIBROSIS AND LYSIS OF ADHESIONS. THE SURGEON INDICATED SIGNIFICANT BONE LOSS AT THE ANTERIOR ASPECT OF THE FLANGE AND THE MEDIAL AND LATERAL FEMORAL CONDYLES DUE TO THE LUGS. HE REPORTED THE TIBIAL TRAY WAS GROSSLY LOOSE AND DE-BONDED FROM THE CEMENT MANTLE. HE NOTED THE PATELLAR COMPONENT HAD NO WEAR AND TRACKED WELL AFTER TRIAL WITH NEW COMPONENTS, SO WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND DEPUY BONE CEMENT X 2. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015, DOR: (B)(6) 2019, (RT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203977 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 8151376 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention