BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 11930188 · Received June 3, 2021

    Report

    Report Number
    1818910-2021-11747
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    December 10, 2018
    Report Date
    May 25, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    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 PREVIOUS DHR (DEVICE HISTORY RECORD) REVIEW (B)(4) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (7915796).

    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

    PRIMARY OPERATIVE NOTES (B)(6) 2015 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND LOOSENING. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE, INTERFACE NOT PROVIDED. THE FEMORAL COMPONENT AND PATELLA WERE NOTED TO BE WELL FIXED AND LEFT IMPLANTED. THE INSERT WAS REVISED WITHOUT INDICATION OF DEFICIENCY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2015. DOR: (B)(6) 2018. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823136 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3122-040 7915796 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ATTUNE FB TIB BASE SZ 6 CEM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FB INSRT SZ 6 10MM| ATTUNE PS FEM RT SZ 6 CEM| SMARTSET MV 40G - EO| SMARTSET MV 40G - EO| ATTUNE FB TIB BASE SZ 6 CEM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FB INSRT SZ 6 10MM| ATTUNE PS FEM RT SZ 6 CEM| SMARTSET MV 40G - EO| SMARTSET MV 40G - EO