BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 17877610 · Received October 5, 2023

    Report

    Report Number
    1818910-2023-20303
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 5, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    PMA / PMN Number
    OUS - SIMILA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DMF# (B)(4). TRADE NAME GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH 1.0G ACTIVE IN OUR CEMENTS. H10 ¿ NO 510K AS DEVICE IS NOT MARKETED IN THE UNITED STATES UNDER THIS PRODUCT CODE, BUT THE SAME/SIMILAR PRODUCT IS MARKETED IN THE US UNDER A DIFFERENT PRODUCT CODE. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, "THE COMPLAINT IS THAT THE CEMENT IS SETTING VERY QUICKLY, THIS HAS HAPPENED ON A COUPLE OF CASES OVER THE PAST FEW WEEKS." LOT: 3980082; MANUFACTURING DATE: 31 OCT 22; EXPIRY DATE: 30 SEP 24; QUANTITY: (B)(4). THERE WAS ONE NON-CONFORMANCE ASSOCIATED WITH 3980082. THE NON-CONFORMANCE WOULD NOT HAVE HAD AN ADVERSE EFFECT ON THE PERFORMANCE OF THE CEMENT. FINAL MICRO AND STERILITY TESTS PASSED. PRODUCT MET ALL QUALITY CONTROL ACCEPTANCE CRITERIA. PRODUCT CHECKED: RETURNED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT HANDLING. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. LOT: 3980082 (SMARTSET GHV GENTAMICIN); DOUGH TIME: 43 SECS (SPEC: 1 MIN 30S MAX); MIX CHARACTERISTICS: THIN; SETTING TIME: 10 MIN 02 SECS (SPEC 8 MIN 30S TO 12 MIN 30 SEC). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET APPROPRIATE SPECIFICATIONS (MS-039 SMARTSET GMV GENTAMICIN BONE CEMENT). AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3095040, LOT 3980082, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE COMPLAINT IS THAT THE CEMENT IS SETTING VERY QUICKLY, THIS HAS HAPPENED ON A COUPLE OF CASES OVER THE PAST FEW WEEKS. WE WERE PROVIDED WITH DETAILS OF THE EFFECTS OF A PRIMARY HIP CASE STATING THE CEMENT SET AFTER 4 MINUTES. THIS RESULTED IN THE SURGEON BEING UNABLE TO IMPLANT THE CEMENTED HIP STEM CORRECTLY AND AS A RESULT THEY HAD TO REVISE THE HIP. THIS ADDED AN ADDITIONAL 1.5 HOURS ONTO THE SURGERY TIME AND THE PATIENT HAD TO HAVE A GENERAL ANAESTHETIC THAT THEY WERE NOT EXPECTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334462 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 3980082

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention DEPUY CMW 1G 40G.| SMARTSET GHV GENTAMICIN 40G.