BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 21987532 · Received May 8, 2025

    Report

    Report Number
    1818910-2025-07429
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    January 1, 2016
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    J&J MEDTECH IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH J&J MEDTECH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, J&J MEDTECH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, J&J MEDTECH, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: "JRN COMBO PRODUCTS: DMF# - 13704 TRADE NAME ¿ GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS." IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> PATIENT STATES HE HAD KNEE REPLACEMENT AROUND 2004, HAD REVISION DONE IN 2016 IN CALIFORNIA BY SURGEON AT A HOSPITAL. HE CONTINUED TO HAVE ISSUES AND IN (B)(6) 2023 WENT TO ANOTHER SURGEON IN ANOTHER HOSPITAL WHO REPLACED WHAT HE CONSIDERED DAMAGED COMPONENTS. HE HAS SPOKEN WITH ATTORNEY. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS AND A VIDEO WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (B)(4) DEVICE VIDEO AD 31 JUL 2024, (B)(4) (DEVICE PHOTO AD 31 JUL 2024 (1), (B)(4) DEVICE PHOTO AD 31 JUL 2024 (2), (B)(4) EXTERNAL KNEE REVISION (2.53 MB). THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED PRODUCT. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PRODUCT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 545035500 LOT NUMBER: 8305274, AND THERE WAS 1 NON-CONFORMANCE ASSOCIATED WITH THIS LOT, HOWEVER THIS IS NOT RELATED TO THE FAILURE MODE OF THE COMPLAINT. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED PRODUCT COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 545035500 LOT NUMBER: 8305274, AND THERE WAS 1 NON-CONFORMANCE ASSOCIATED WITH THIS LOT, HOWEVER THIS IS NOT RELATED TO THE FAILURE MODE OF THE COMPLAINT. ADDED: D10 CONCOMITANT.

    Description of Event or Problem · 0

    MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR:(B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS THAT WAS TREATED WITH IMPACTION BONE GRAFTING. THE PATIENT WAS REVISED WITH COMPETITOR CEMENT AND DEPUY TC3 IMPLANTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016 DOR (B)(6) 2023 RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848204 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 8305274 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention LCS CRUC M/B PAT REPLC GVF LG+| MBT REVISION CEM TIB TRAY SZ 5| PFC*SIGMA TC3 FEM RT SZ5| SIG FEM ADAP +2/-2 OFFSET BOLT| SIGMA FEM ADAPTER 5 DEGREE| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| TC3 RP TIBIAL INSERT S5,20.0