BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 11581026 · Received March 29, 2021

    Report

    Report Number
    1818910-2021-06265
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    October 9, 2017
    Report Date
    March 25, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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 : DEVICE HISTORY REVIEWED: 8201993 1 NRELATED NON-CONFORMANCE ON THIS LOT NUMBER FINAL MICRO AND STERILITY TESTS PASSED ALL QC RELEASE SPECIFICATIONS MET (B)(4) UNITS RELEASED LOT EXPIRY DATE: 31 OCTOBER 2017.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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) 2016: PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS FOR OSTEOARTHRITIS. DEPUY IMPLANS PLACED WITH DEPUY CEMENT X2 (BOTH KNEES). NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2017: PATIENT UNDERWENT A RIGHT KNEE REVISION FOR PAIN AND MID FLEXION INSTABILITY. A RARE GRAM+ COCCI WAS FOUND ON CULTURES, BUT WAS THOUGHT TO BE A CONTAMINATE GIVEN THE CLINICAL PICTURE. THE TIBIAL TRAY WAS FOUND TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY AND INSERT WERE REVISED. THE FEMORAL COMPONENT AND PATELLA WERE LEFT IMPLANTED WITH NO ALLEGATIONS. DEPUY TIBIAL TRAY, TIBIAL STEM, AND INSERT WERE PLACED. COMPETITORT CEMENT WAS USED AT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479349 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3092-040 8201993 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ATTUNE MEDIAL ANAT PAT 35MM| ATTUNE PS FEM RT SZ 5 NAR CEM| ATTUNE PS RP INSRT SZ 5 12MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET HV BONE CEMENT 40G| SMARTSET HV BONE CEMENT 40G| ATTUNE MEDIAL ANAT PAT 35MM| ATTUNE PS FEM RT SZ 5 NAR CEM| ATTUNE PS RP INSRT SZ 5 12MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET HV BONE CEMENT 40G| SMARTSET HV BONE CEMENT 40G