BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 8109986 · Received November 28, 2018

    Report

    Report Number
    1818910-2018-76441
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    May 31, 2016
    Report Date
    November 2, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED: 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND ADDITIONAL REPORTS, HOWEVER NO OTHER INCIDENTS RELATED TO SYNOVIAL HYPOPLASIA (ADVERSE TISSUE REACTION) TOTAL FOR LOT NUMBER: 11 (COM-080109, COM-162801, COM-165773, COM-194654, COM-257777, COM-330835, (B)(4)) . COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 1, BY PRODUCT FAMILY: 6 (5X SMARTSET HV, 1X SMARTSET MV).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: CORRECTED: H6 (DEVICE CODE). THE DEVICE CODE MIGRATION IS BEING RETRACTED SINCE IT WAS REPORTED IN ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING. LOOSENING OCCURRED AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953326 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3122-040 7807504 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention