BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 10241092 · Received July 7, 2020

    Report

    Report Number
    1818910-2020-15195
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    October 25, 2019
    Report Date
    April 9, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174288
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    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: A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON (B)(4). THE DHR REVIEW REVEALED OF THE (B)(4), BATCH, ZERO NON-CONFORMANCES OF THIS LOT WERE IDENTIFIED. FINAL MICRO AND STERILITY TESTS PASSED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (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

    MEDICAL RECORDS AD 30 MAR 2020 WERE REVIEWED. ON (B)(6) 2017, THE PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS. DEPUY COMPONENTS WERE USED WITH DEPUY CEMENT X2 TOTAL FOR EACH KNEE. THERE WERE NO COMPLICATIONS NOTED. PFS NOTES REVISION ON 25 OCT 2019, BUT NO REVISION MEDICAL RECORDS WERE PROVIDED. MEDICAL RECORDS ((B)(4) MEDICAL RECORDS AD 12 JUN 2020) REVIEWED. ON (B)(6) 2019, LEFT KNEE WAS REVISED DUE TO ATTUNE TIBIAL TRAY LOOSENING. REVISION OPERATIVE NOTES INDICATED THAT THE PATIENT EXPERIENCED PAIN PRE-OPERATIVELY. INTRAOPERATIVELY, THE FEMUR COMPONENT WAS FOUND TO BE WELL-FIXED, WITH GOOD CEMENT INTERDIGITATION TO THE IMPLANT AND TO BONE. IN CONTRAST, A SINGLE OSTEOTOME TAP TO THE CEMENT TO IMPLANT INTERFACE FREED THE IMPLANT ENTIRELY FROM THE CEMENT MANTLE, WHICH WAS WELL-FIXED TO THE TIBIA BONE. THE FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED TO COMPETITOR REVISION PRODUCTS--THE PATELLA WAS RETAINED. ACTIVITY HAS BEEN INITIATED FOR ADDITION OF IMPLANT LOOSENING CODE - CEMENT TO IMPLANT INTERFACE TO TIBIAL TRAY AND CEMENT PRODUCTS, AND PATIENT PAIN CODE TO ALL IMPACTED PRODUCTS. DOI:(B)(6) 2017 DOR:(B)(6) 2019 (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704762 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-35-500 8404195 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM LT SZ 4 CEM| ATTUNE PS RP INSRT SZ4 6MM| ATTUNE RP TIB BASE SZ 4 CEM| SMARTSET GHV GENTAMICIN 40G