BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 10897329 · Received November 24, 2020

    Report

    Report Number
    1818910-2020-25408
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    December 11, 2019
    Report Date
    November 13, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K023012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND ONE ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED SMARTSET HV BONE CEMENT 40G PRODUCT CODE 3092040, LOT NUMBER 8068933 COMBINATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. 2 UNRELATED NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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) 2015: PATIENT UNDERWENT A LEFT KNEE ATTUNE ARTHROPLASTY. THE PATELLA WAS RESURFACED, AND CEMENT MANUFACTURER WAS DEPUY. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2019: PATIENT UNDERWENT A LEFT KNEE REVISION AFTER PRESENTING WITH KNEE PAIN AND DECREASED ROM. NO OBVIOUS SIGNS OF LOOSENING VIA X-RAY, AND CT SCAN DID INDICATE SOME INCREASED UPDATE AROUND THE TIBIAL COMPONENT. THE REVISION OPERATIVE NOTE DIDN'T CONFIRM OR INDICATE ANY LOOSENING OF THE TIBIAL TRAY. THE REVISION OPERATIVE NOTE FOR HER RIGHT KNEE DID INDICATE THE REVISION OF THE PATIENT'S LEFT KNEE WAS INDEED FOR TIBIAL COMPONENT LOOSENING. LOOSENING INTERFACE IS BELIEVED TO BE AT THE CEMENT TO IMPLANT AS THE CEMENT MANTLE WAS INTACT. THE PATELLAR AND FEMORAL COMPONENT WERE LEFT IMPLANTED WITH NO DEFICIENCIES NOTED. ATTUNE REVISION IMPLANTS WERE PLACED ON THE TIBIAL SIDE. DOI: (B)(6) 2015; DOR: (B)(6) 2019; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357656 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3092-040 8068933 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS FEM LT SZ 4 CEM| ATTUNE PS RP INSRT SZ4 5MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET HV BONE CEMENT 40G