BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 11857035 · Received May 20, 2021

    Report

    Report Number
    1818910-2021-10828
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 11, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174288
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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: 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

    PRODUCT COMPLAINT #: (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. DMF# - (B)(4). (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 RECEIVED AD 23 APR 2021 WERE REVIEWED ON 11 MAY 2021 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PRIMARY OPERATIVE NOTES (B)(6) 2015 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES 03/04/2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO COMPONENT LOOSENING. UPON ENTERING THE JOINT, SCARRING WAS ENCOUNTERED AND REMOVED. FINDINGS INCLUDE SYNOVITIS, INSTABILITY, SUBSIDENCE OF TIBIAL COMPONENT ALONG WITH LOOSENING AT THE CEMENT TO IMPLANT. INSERT, TIBIAL AND FEMORAL COMPONENTS REPLACED WITH COMPETITOR PRODUCTS. PATELLA WAS NOT REVISED, NO DEFICIENCY NOTED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753393 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-35-500 8053415 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM RT SZ 6 CEM| ATTUNE PS RP INSRT SZ6 5MM| ATTUNE RP TIB BASE SZ 5 CEM| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G