BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 18541760 · Received January 19, 2024

    Report

    Report Number
    1818910-2024-01306
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 18, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) E3: THE INITIAL REPORTER INFORMATION HAS BEEN REMOVED FOR CONFIDENTIALITY/PRIVACY. THE INITIAL REPORTER IS A PATIENT. 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. DMF# - 13704 TRADE NAME ¿ GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 545050501, LOT - 8647290 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. MANUFACTURING DATE: 2017-10-12. EXPIRY DATE: 2019-09-30. QUANTITY: (B)(4). THERE WERE ZERO NONCONFORMANCE ON THIS LOT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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 REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAS CONCERN ABOUT ATTUNE DEPUY KNEE REPLACEMENT. THE PATIENT HAS BEEN EXPERIENCING PAIN, SWELLING, EFFUSION, AND THE FEELING LIKE HER KNEE IS GIVING OUT. THE PATIENT IS MEETING WITH A SURGEON TO DISCUSS POTENTIAL REVISION. DOI: (B)(6) 2018 AFFECTED SIDE: LEFT KNEE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122936 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 8647290 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention ATTUNE FB TIB BASE SZ 5 CEM| ATTUNE PS FB INSRT SZ 5 7MM| ATTUNE PS FEM LT SZ 5 CEM| SMARTSET GMV 40G US EO