BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 19251042 · Received May 6, 2024

    Report

    Report Number
    1818910-2024-09949
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 6, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (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. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. 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: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO TIBIAL LOOSENING. DATE OF IMPLANT: (B)(6) 2022 DATE OF REVISION: (B)(6) 2024 (RIGHT KNEE) TREATMENT: TIBIAL BASE WAS REVISED DEPUY PRODUCTS USED: CATALOG ID: 3092040 LOT NUMBER/PRODUCT IDENTIFIER: 3684072 COMPONENT TYPE: CEMENT DESCRIPTION: SMARTSET HV BONE CEMENT 40G CATALOG ID: 151214050 LOT NUMBER/PRODUCT IDENTIFIER: D22090087 COMPONENT TYPE: STEM DESCRIPTION: ATTUNE REVISION CEMENTED STEM 14 MM X 50 MM CATALOG ID: 154906002 LOT NUMBER/PRODUCT IDENTIFIER: M1084N COMPONENT TYPE: ACC DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SIZE 6 8 MM CATALOG ID: 150410206 LOT NUMBER/PRODUCT IDENTIFIER: M1997H COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE POST/STAB FEM LT SZ 6 CEMENTED CATALOG ID: 151316060 LOT NUMBER/PRODUCT IDENTIFIER: D23042937 COMPONENT TYPE: STEM DESCRIPTION: ATTUNE REVISION PRESSFIT STEM 16 MM X 60 MM CATALOG ID: 151111202 LOT NUMBER/PRODUCT IDENTIFIER: M3420Y COMPONENT TYPE: SLEEVE DESCRIPTION: ATTUNE REVISION TIBIAL SLEEVE POROCOAT FULLY COATED 37 MM CATALOG ID: 150660006 LOT NUMBER/PRODUCT IDENTIFIER: 4036377 COMPONENT TYPE: TIBIAL DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED CATALOG ID: 151710614 LOT NUMBER/PRODUCT IDENTIFIER: 9927036 COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 6 14 MM - WERE DEPUY COMPONENTS REMOVED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776373 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY IRELAND - 3015516266 3684072 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention ATTUNE CEMENTED STEM 14X50MM| ATTUNE CRS RP INSRT SZ 6 14MM| ATTUNE POS FEM AUG SZ 6 8MM| ATTUNE PS FEM RT SZ 6 CEM| ATUN TIB SLV M/L 37MM FULL POR| ATUNE PRESSFIT STR STEM16X60MM| ATUNE REV RP TIB BASE SZ 6 CEM