BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 7650087 · Received June 29, 2018

    Report

    Report Number
    1818910-2018-63496
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    March 27, 2018
    Report Date
    July 31, 2018
    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
    AL, US
    Reporter Occupation
    OTHER CAREGIVERS

    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 BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 5 ADDITIONAL REPORTS; 2 FOR UNRELATED ISSUES, AND 3 FOR IMPLANT LOOSENING. TOTAL FOR LOT NUMBER: 5 (B)(6), (B)(6), (B)(6), (B)(6), (B)(6). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 77. BY PRODUCT FAMILY: 134 (50X SMARTSET HV, 84X SMARTSET MV). H10 ADDITIONAL NARRATIVE: ADDED: H6 (PATIENT) CORRECTED: D3. H6 PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.  UDI: (B)(4).

    Description of Event or Problem · 0

    MEDICAL RECORDS ALLEGES ADHESION.

    Additional Manufacturer Narrative · 1

    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 BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 5 ADDITIONAL REPORTS; 2 FOR UNRELATED ISSUES, AND 3 FOR IMPLANT LOOSENING. TOTAL FOR LOT NUMBER: 5 (B)(4)). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 77. BY PRODUCT FAMILY: 134 (50X SMARTSET HV, 84X SMARTSET MV). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE MEDICAL RECORDS RECEIVED ON 6 JUNE 2018 WERE REVIEWED ON 06/27/2018. THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL BASE AT UNKNOWN INTERFACE. THE CEMENT IS DEPUY CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493970 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY CMW ¿ 9610921 3122-040 3566119 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention