BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 24844045 · Received April 10, 2026

    Report

    Report Number
    1818910-2026-06578
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 24, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295357094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B3, B5, H6. (HEALTH EFFECT - IMPACT CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: 1. HOW WAS THE CEMENT PREPARED FOR USE? -THE POWDER AND LIQUID WERE BEING MIXED IN CIRCULAR MOTION IN A CEMENT BOWL WITH A SPATULA. 2. WHAT EQUIPMENT WAS USED TO PREPARE / MIX THE CEMENT? - DISPOSABLE CEMENT BOWL AND SPATULA. 3. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? - THE MIXING TIME WAS LESS THAN 1 MINUTE AND THE TOTAL SETTING TIME IS 14 MINUTES. 4. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? - THE CEMENT IS PLACED IN A CONTAINER AND BEING TRANSPORTED FROM WAREHOUSE TO HOSPITAL BY VAN. 5. WHAT WAS THE STORAGE TEMPERATURE OF THE CEMENT PRIOR TO USAGE? - LOWER THAN ROOM TEMPERATURE. 6. PLEASE CONFIRM THE MANUFACTURER FOR THE CEMENT PRODUCT AND PROVIDE THE PRODUCT DETAILS. - MANUFACTURER: DEPUY IRELAND UC LOUGHBEG, RINGASKIDDY, CO CORK, IRELAND. - PRODUCT NAME: SMARTSET GHV GENTAMICIN BONE CEMENT. - LOT NUMBER: 4674655. - REFERENCE NUMBER: (B)(4). 7. CAN YOU PLEASE PROVIDE THE EVENT DATE? - 24TH MARCH OF 2026. 8. DEVICE FOLLOW-UP: IS THE PRODUCT STILL AVAILABLE FOR RETURN? - YES, IT IS CURRENTLY IN THE OFFICE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT SMARTSET GHV GENTAMICIN 40G FAILED TO HARDEN OR HEAT UP AS EXPECTED AFTER 14 MINUTES, CRUMBLING INTO SMALL PIECES WHEN COMPRESSED. THIS RESULTED IN DIFFICULTIES IMPACTING THE IMPLANTS TO THE BONE, AND THE SURGERY WAS DELAYED BY FIVE MINUTES. THE IMPLANTS WERE FORCED IN, AND NO ADVERSE REACTIONS WERE OBSERVED POST-OPERATIVELY, THOUGH THE LONG-TERM FIXATION OF THE IMPLANTS REMAINS UNCERTAIN. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AT THE TIME, AND POST-OPERATIVE IMAGING SHOWED NO IRREGULARITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906388 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 4674655 10603295357094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown