BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 12319641 · Received August 13, 2021

    Report

    Report Number
    1818910-2021-17841
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    August 20, 2019
    Report Date
    July 23, 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. 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 : PREVIOUS DHR REVIEW (B)(4) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (7122502).

    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

    (B)(6) 2014: PATIENT UNDERWENT A LEFT TKA FOR DEGENERATIVE ARTHRITIS. PATELLA WAS RESURFACED AND DEPUY CEMENT WAS USED. NO COMPLICATIONS NOTED. (B)(6) 2019: PATIENT UNDERWENT A LEFT TKA REVISION DUE TO ASEPTIC LOOSENING. THE PATELLA WAS RETAINED, BUT ALL OTHER IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR IMPLANTS. THE POLY INSERT HAD SIGNIFICANTLY WORN WITH FRAYING AND PITTING ON THE MEDIAL SIDE. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE - NO LOOSENING INTERFACE WAS NOTED BUT THE CEMENT MANTLE NEEDED TO BE REMOVED FROM THE TIBIAL BONE. DOI: (B)(6) 2014, DOR: (B)(6) 2019 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216986 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3122-040 7122502 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ATTUNE FB TIB BASE SZ 4 CEM| ATTUNE MEDIAL DOME PAT 32MM| ATTUNE PS FB INSRT SZ 6 6MM| ATTUNE PS FEM LT SZ 6 NAR CEM| SMARTSET GMV 40G US EO| SMARTSET MV 40G - EO| ATTUNE FB TIB BASE SZ 4 CEM| ATTUNE MEDIAL DOME PAT 32MM| ATTUNE PS FB INSRT SZ 6 6MM| ATTUNE PS FEM LT SZ 6 NAR CEM| SMARTSET GMV 40G US EO| SMARTSET MV 40G - EO