BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL TRAY ATTUNE RP

    MDR report key: 19752523 · Received July 16, 2024

    Report

    Report Number
    1818910-2024-15241
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    July 1, 2021
    Report Date
    July 16, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    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). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HEGDE V, BRACEY DN, BRADY AC, KLEEMAN-FORSTHUBER LT, DENNIS DA, JENNINGS JM. A PROPHYLACTIC TIBIAL STEM REDUCES RATES OF EARLY ASEPTIC LOOSENING IN PATIENTS WITH SEVERE PREOPERATIVE VARUS DEFORMITY IN PRIMARY TOTAL KNEE ARTHROPLASTY. J ARTHROPLASTY. 2021 JUL;36(7):2319-2324. DOI: 10.1016/J.ARTH.2021.01.049. EPUB 2021 JAN 23. PMID: 33583669. 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: HEGDE V, BRACEY DN, BRADY AC, KLEEMAN-FORSTHUBER LT, DENNIS DA, JENNINGS JM. A PROPHYLACTIC TIBIAL STEM REDUCES RATES OF EARLY ASEPTIC LOOSENING IN PATIENTS WITH SEVERE PREOPERATIVE VARUS DEFORMITY IN PRIMARY TOTAL KNEE ARTHROPLASTY. J ARTHROPLASTY. 2021 JUL;36(7):2319-2324. DOI: 10.1016/J.ARTH.2021.01.049. EPUB 2021 JAN 23. PMID: 33583669. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY ANALYZES THE EFFECT OF A TIBIAL STEM ON THE RATE OF ASEPTIC LOOSENING IN PATIENTS WITH A SEVERE PREOPERATIVE VARUS DEFORMITY. FAILURE WAS DEFINED AS REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK KNEE TIBIAL TRAY ATTUNE RP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL TRAY ATTUNE RP (QTY 3): INCLUDE ADVERSE EVENT(S) WITH QUANTITY AND INTERVENTION(S). TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE REQUIRING DEVICE REVISION (QTY 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505123 UNK KNEE TIBIAL TRAY ATTUNE RP KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention