BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 11655803 · Received April 13, 2021

    Report

    Report Number
    1818910-2021-07774
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 26, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174288
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. 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 : A PREVIOUS DHR REVIEW, PER COM-182973, DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT AND LOT COMBINATION.

    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. THE SURGEON REMOVE AND REPLACE TIBIAL AND POLY COMPONENT. REPLACED WITH ATTUNE REVISION TRAY AND SLEEVE. POLY WAS REPLACED TO CONFORM WITH REVISION TRAY. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2021; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555408 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-35-500 7797731 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ATTUNE FB TIB BASE SZ 4 CEM| ATTUNE PS FB INSRT SZ 5 10MM