BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 20735985 · Received November 20, 2024

    Report

    Report Number
    1818910-2024-24184
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    November 12, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 VILE OF LIQUID IN CEMENT BOX WAS CRACKED AND LEAKING. IT DID NOT HAPPEN IN SURGERY." PRODUCT DESCRIPTION:- SMARTSET MV 40G PRODUCT CODE:- 3122040 LOT NO:- 4382793 QUANTITY OF MANUFACTURED:- 2870 DATE OF MANUFACTURING:- 08-FEB-2024 EXPIRY DATE:- 31-JAN-2026 TESTING COULD NOT BE COMPLETED AS THE RETAINED SAMPLES ARE NO LONGER AVAILABLE FOR TESTING. THERE WAS 1 NON-CONFORMANCES ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY (SEE PAGE 2). LOT: 4382793 DOUGH TIME: 02 MIN 53S (SPEC: 05 MIN 00S MAX) MIX CHARACTERISTICS: SOFT. SETTING TIME: 11 MIN 12S (SPEC: 09 MIN TO 13 MIN 30S). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (MS-037 MASTER SPECIFICATION: SMARTSET MV) 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 ==> PRODUCT DESCRIPTION: - SMARTSET MV 40G PRODUCT CODE:- 3122040 LOT NO:- 4382793 QUANTITY OF MANUFACTURED: - 2870 DATE OF MANUFACTURING: - 08-FEB-2024 EXPIRY DATE: - 31-JAN-2026 DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VIAL OF LIQUID IN CEMENT BOX WAS CRACKED AND LEAKING. IT DID NOT HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000251 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 4382793 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown