BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK CEMENT GENTAMICIN

    MDR report key: 19011350 · Received April 1, 2024

    Report

    Report Number
    1818910-2024-07078
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    November 1, 2023
    Report Date
    April 1, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    MBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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 DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: VAN DER LELIJ TJN, MARANG-VAN DE MHEEN PJ, KAPTEIN BL, TOKSVIG-LARSEN S, NELISSEN RGHH. CONTINUED STABILIZATION OF A CEMENTLESS 3D-PRINTED TOTAL KNEE ARTHROPLASTY: FIVE-YEAR RESULTS OF A RANDOMIZED CONTROLLED TRIAL USING RADIOSTEREOMETRIC ANALYSIS. J BONE JOINT SURG AM. 2023 NOV 1;105(21):1686-1694. DOI: 10.2106/JBJS.23.00221. EPUB 2023 AUG 31. PMID: 37651549; PMCID: PMC10609712. OBJECTIVE AND METHODS: AUTHORS SOUGHT TO INVESTIGATE THREE-DIMENSIONAL (3D) PRINTING OF HIGHLY POROUS ORTHOPAEDIC IMPLANTS (COMPETITOR BRAND), WHICH AIM TO PROMOTE BETTER OSSEOINTEGRATION, THUS PREVENTING ASEPTIC LOOSENING. AUTHORS COMPARED THE MIGRATION OF A CEMENTLESS 3D-PRINTED TIBIAL COMPONENT AND A CEMENTED TIBIAL COMPONENT WITH OTHERWISE SIMILAR TKA DESIGN DURING 5 YEARS OF FOLLOW-UP, PARTICULARLY THE PROGRESSION IN MIGRATION BEYOND 2 YEARS POSTOPERATIVELY. SEVENTY-TWO PATIENTS WERE RANDOMIZED TO A CEMENTLESS 3D-PRINTED COMPETITOR CRUCIATE-RETAINING (CR) TKA OR A COMPETITOR CR TKA IMPLANT. DEPUY SMARTSET GHV BONE CEMENT WAS USED FOR ALL CEMENTED TIBIAL TRAY COMPONENTS. IMPLANT MIGRATION WAS EVALUATED WITH RADIO-STEREOMETRIC ANALYSIS (RSA) AT BASELINE AND POSTOPERATIVELY AT 3 MONTHS AND AT 1, 2, AND 5 YEARS. THE MAXIMUM TOTAL POINT MOTION (MTPM) OF THE TIBIAL COMPONENT WAS COMPARED BETWEEN THE GROUPS AT 5 YEARS, AND PROGRESSION IN MIGRATION WAS ASSESSED BETWEEN 2 AND 5 YEARS. INDIVIDUAL IMPLANTS WERE CLASSIFIED AS CONTINUOUSLY MIGRATING IF THE MTPM WAS =0.1 MM/YEAR BEYOND 2 YEARS POSTOPERATIVELY. CLINICAL SCORES WERE EVALUATED, AND A LINEAR MIXED-EFFECTS MODEL WAS USED TO ANALYZE REPEATED MEASUREMENTS. AUTHORS DID NOT PROVIDE ANT SPECIFIC PRODUCT OR LOT CODE INFORMATION FOR EACH PATIENT, NOR WERE PATIENTS BROKEN OUT BY CASE NUMBER OR AGE/GENDER DEMOGRAPHIC DATA. RESULTS: AT 5 YEARS, THE MEAN MTPM WAS 0.66 MM FOR THE CEMENTLESS GROUP AND 0.53 MM FOR THE CEMENTED GROUP. BETWEEN 2 AND 5 YEARS, THERE WAS NO PROGRESSION IN MEAN MTPM FOR THE CEMENTLESS GROUP VERSUS 0.07 MM FOR THE CEMENTED GROUP. ONE IMPLANT WAS CONTINUOUSLY MIGRATING IN THE CEMENTLESS GROUP, AND 4 WERE CONTINUOUSLY MIGRATING IN THE CEMENTED GROUP. THE CLINICAL SCORES WERE COMPARABLE BETWEEN THE GROUPS ACROSS THE ENTIRE TIME OF FOLLOW-UP. CONCLUSIONS: NO SIGNIFICANT DIFFERENCE IN MEAN MIGRATION WAS FOUND AT 5 YEARS BETWEEN THE CEMENTLESS AND CEMENTED TKA IMPLANTS. PROGRESSION OF TIBIAL COMPONENT MIGRATION WAS PRESENT BEYOND 2 YEARS FOR THE CEMENTED IMPLANT, WHEREAS THE CEMENTLESS IMPLANT REMAINED STABLE AFTER INITIAL EARLY MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362118 UNK CEMENT GENTAMICIN BONE CEMENT MBB DEPUY IRELAND - 3015516266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown