BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 9781791 · Received March 3, 2020

    Report

    Report Number
    1818910-2020-06726
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    September 5, 2019
    Report Date
    September 5, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295174288
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 : A PREVIOUS DHR REVIEW (B)(4) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (8053415).

    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 PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. ON (B)(6) 2015: PATIENT UNDERWENT A PRIMARY KNEE REPLACEMENT. DEPUY IMPLANTS WERE IMPLANTED WITH DEPUY CEMENT X2. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2019: PATIENT PRESENTED WITH PAIN AND UNDERWENT A RIGHT KNEE REVISION. THE TIBIAL TRAY WAS NOTED TO BE IN VARUS AND LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE FEMORAL COMPONENT AND PATELLA WERE NOTED TO BE WELL FIXED AND RETAINED. ATTUNE REVISION IMPLANTS WERE USED WITH DEPUY CEMENT. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244178 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 5450-35-500 8053415 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM RT SZ 5 CEM| ATTUNE PS RP INSRT SZ 5 7MM| ATTUNE RP TIB BASE SZ 5 CEM| SMARTSET GHV GENTAMICIN 40G