BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 17650306 · Received August 30, 2023

    Report

    Report Number
    1818910-2023-17821
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 30, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. 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)(6). MF# - 13704 TRADE NAME GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH 1.0G ACTIVE IN OUR CEMENTS. 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, "IT WAS REPORTED THAT THE GMV CEMENT HARDENED TOO QUICKLY AND WAS NOT ABLE TO SHOOT IN A CEMENT GUN. THIS HAPPENED IN 3 ATTEMPTS MIXING CEMENT DURING THE CASE. AFTERWARDS, A TOTAL MIX WAS ATTEMPTED WITH A BATCH OF CEMENT AND THE SAME THING HAPPENED. IT'S ALMOST LIKE THE GMV CEMENT IS ACTING LIKE THE GHV CEMENT. THERE WAS A SURGICAL DELAY OF 10-15 MINS." A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 545050501 LOT NUMBER: 4047303, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. LOT: 4047303, MANUFACTURING DATE: 23 JAN 23, EXPIRY DATE: 31 DEC 24, QUANTITY: (B)(4). PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME .THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH. DOUGH TIME: 02 MIN 48 SECS MIX CHARACTERISTICS: OK SETTING TIME: 10 MIN 29 SEC. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (REF (B)(4) SMARTSET GMV GENTAMICIN BONE CEMENT MASTER SPECIFICATION). SETTING TIME WAS TESTED USING TM-T150. THE RECORDED SETTING MET THE CONTROL SPECIFICATION OF 9.0 ¿ 13.5 (9 MIN TO 13 MIN 30S). 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 PRODUCT CODE: 545050501 LOT NUMBER: 4047303, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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, "IT WAS REPORTED THAT THE GMV CEMENT HARDENED TOO QUICKLY AND WAS NOT ABLE TO SHOOT IN A CEMENT GUN. THIS HAPPENED IN 3 ATTEMPTS MIXING CEMENT DURING THE CASE. AFTERWARDS, A TOTAL MIX WAS ATTEMPTED WITH A BATCH OF CEMENT AND THE SAME THING HAPPENED. IT'S ALMOST LIKE THE GMV CEMENT IS ACTING LIKE THE GHV CEMENT. THERE WAS A SURGICAL DELAY OF 10-15 MINS.". A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE:545050501 LOT NUMBER:4047303, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. LOT: 4047303. MANUFACTURING DATE: 23 JAN 23. EXPIRY DATE: 31 DEC 24. QUANTITY: (B)(4). PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME .THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH. DOUGH TIME: 02 MIN 48 SECS. MIX CHARACTERISTICS: OK. SETTING TIME: 10 MIN 29 SEC. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THEAPPROPRIATE CONTROL SPECIFICATION (REF MS-008 SMARTSET GMV GENTAMICIN BONE CEMENT MASTER SPECIFICATION). SETTING TIME WAS TESTED USING TM-T150. THE RECORDED SETTING MET THE CONTROL SPECIFICATION OF 9.0 ¿ 13.5 (9 MIN TO 13 MIN 30S) . 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 PRODUCT CODE:545050501 LOT NUMBER:4047303, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: 1. CAN YOU CONFIRM THE QUANTITY OF THE REPORTED PRODUCTS? QTY: (B)(4). 2. HOW WAS THE CEMENT PREPARED FOR USE? IT WAS MIXED IN A MIXING TOWER FOR 1 MINUTE. IT WAS THEN MIXED FOR 30 SECONDS IN A MIXING TOWER THE NEXT ATTEMPTS & STILL HARDENED TOO QUICKLY BEFORE BEING PUT INTO A CEMENT GUN. 3. WHAT EQUIPMENT WAS USED TO PREPARE/MIX THE CEMENT? HOSPITAL-OWNED STRYKER MIXING TOWER. 4. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? MIX WAS 1 MINUTE AND THE TIME BETWEEN MIXING AND SETTING WAS 2-3 MINUTES. 5. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? WAS GOING TO BE A CEMENT GUN. 6. CAN YOU PROVIDE THE QUANTITY USED FOR THE CEMENT PRODUCT? QTY OF (B)(4) WAS USED IN THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GMV CEMENT HARDENED TOO QUICKLY AND WAS NOT ABLE TO SHOOT IN A CEMENT GUN. THERE WAS A SURGICAL DELAY OF 10-15 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413663 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY IRELAND - 9616671 4047303 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO