BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 9687395 · Received February 10, 2020

    Report

    Report Number
    1818910-2020-04352
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    March 21, 2019
    Report Date
    March 21, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS CONFIRMED THE REPORTED EVENT. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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: 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

    (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

    REVISION OF A PRIMARY ATTUNE TOTAL KNEE REPLACEMENT DONE AT OUTSIDE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152509 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3122-040 7915796 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM