BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 19992757 · Received August 15, 2024

    Report

    Report Number
    1818910-2024-17504
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    August 26, 2022
    Report Date
    August 15, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PIRES E ALBUQUERQUE RS, SOUSA FILHO PGT, MORAES RFP, FRANCO FILHO DRM, MOZELLA A, COBRA H, GAMEIRO VS. STUDY BETWEEN SEMI-CONSTRAINED TOTAL KNEE ARTHROPLASTY WITH OR WITHOUT INTRAMEDULLARY STEM. ACTA ORTOP BRAS. 2022 AUG 26;30(4): E250492. DOI: 10.1590/1413-785220223004E250492. PMID: 36092171; PMCID: PMC9425980. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PIRES E ALBUQUERQUE RS, SOUSA FILHO PGT, MORAES RFP, FRANCO FILHO DRM, MOZELLA A, COBRA H, GAMEIRO VS. STUDY BETWEEN SEMI-CONSTRAINED TOTAL KNEE ARTHROPLASTY WITH OR WITHOUT INTRAMEDULLARY STEM. ACTA ORTOP BRAS. 2022 AUG 26;30(4):E250492. DOI: 10.1590/1413-785220223004E250492. PMID: 36092171; PMCID: PMC9425980. OBJECTIVE/METHODS/STUDY DATA: THIS RESEARCH AIMS TO CONDUCT A COMPARATIVE STUDY OBSERVING THE CLINICAL AND RADIOGRAPHIC ANALYSIS OF TC3 JOHNSON® PRIMARY PROSTHESES WITH OR WITHOUT STEM DURING A SHORT-TERM FOLLOW-UP. THE SAMPLE CONSISTED OF PATIENTS OF ALL GENDERS AND AGES, WHO UNDERWENT PRIMARY TKA IN THE HOSPITAL WITH THE TC3 DEPUY JOHNSON® PROSTHESIS WHO WERE ADMITTED FOR TREATMENT FROM 2012 TO 2016. THE INCLUSION CRITERIA WERE: PATIENTS SUBJECTED TO PRIMARY TKA WITH TC3 DEPUY JOHNSON® PROSTHESIS, REGARDLESS OF THE USE OR NOT OF INTRAMEDULLARY STEMS. THE SAMPLE WAS DIVIDED INTO THREE GROUPS: GROUP 1 (N=20) WITH STEM IN BOTH TIBIAL AND FEMORAL COMPONENTS, GROUP 2 (N=14) WITHOUT STEMS AND GROUP 3 WITH A MIXED APPROACH, I.E., WITH STEM IN THE TIBIAL COMPONENT. THE MEAN FOLLOW-UP WAS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN KNEE TIBIAL TRAY AND UNK KNEE CONSTRUCT TC3 ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE TIBIAL TRAY (QTY.6) (N=4) IMPLANT LOOSENING; NO TREATMENT INTERVENTION. (N=2) TIBIAL COMPONENT LOOSENING; NO TREATMENT INTERVENTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT TC3 (QTY.2) (N=1) LIGAMENTOUS INSTABILITY; NO TREATMENT INTERVENTION. (N=1) JOINT DEFORMITY; NO TREATMENT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200625 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown