BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE STEM ATTUNE REVISION

    MDR report key: 18695310 · Received February 13, 2024

    Report

    Report Number
    1818910-2024-03042
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 1, 2023
    Report Date
    February 13, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE SIZE OF THE ARTICLE IS TOO LARGE TO ATTACH/SUBMIT WITH THE 3500A SUBMISSION. THE CITATION OF THE ARTICLE HAS BEEN PROVIDED BELOW: ARTICLE ENTITLED " PRELIMINARY OUTCOMES FOLLOWING REVISION TOTAL KNEE ARTHROPLASTY USING A NEW FIXED-BEARING REVISION KNEE SYSTEM IN ASIANS: A MEAN OF 3-YEAR FOLLOW-UP" WRITTEN BY OOG JIN SHON, GI BEOM KIM, AND HYUCK GOO KIM PUBLISHED IN JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH IN 2023 WAS REVIEWED. D4-THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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

    ARTICLE ENTITLED " PRELIMINARY OUTCOMES FOLLOWING REVISION TOTAL KNEE ARTHROPLASTY USING A NEW FXED-BEARING REVISION KNEE SYSTEM IN ASIANS: A MEAN OF 3-YEAR FOLLOW-UP" WRITTEN BY OOG JIN SHON, GI BEOM KIM, AND HYUCK GOO KIM PUBLISHED IN JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH IN 2023 WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE EARLY OUTCOMES OF THE NEW SEMI-CONSTRAINED REVISION TOTAL KNEE ARTHROPLASTY (TKA) SYSTEM BY PERFORMING SUBGROUP ANALYSIS ACCORDING TO THE REVISION CAUSE. 75 KNEES WERE INCLUDED WITHIN THE STUDY. ALL PATIENT UNDERWENT A REVISION WITH CEMENTED ATTUNE REVISION SYSTEM BEING PLACED. PATELLAR RESURFACING WASN¿T INCLUDED ON ALL PATIENTS. CEMENT MANUFACTURER WAS NOT INCLUDED. THE ORIGINAL JOINT LINE WAS RESTORED BY APPLYING DISTAL METAL AUGMENTS TO THE FEMORAL BONE DEFECT. BOTH FEMORAL AND TIBIAL STEMS WERE USED IN ALL PATIENTS. ADVERSE EVENTS/COMPLICATIONS: -PROXIMAL DEEP VEIN THROMBOSIS WAS FOUND IN 3 PATIENTS AND DISTAL DEEP VEIN THROMBOSIS WAS FOUND IN 8 PATIENTS. - AFTER THE OPERATION, DYSURIA WAS OBSERVED IN 10 PATIENTS. - ONE PATIENT UNDERWENT RE-REVISION TKA INCLUDING DEBRIDEMENT AND THICKER PE EXCHANGE DUE TO RECURRENCE OF INFECTION. -CARDIOVASCULAR (2 PATIENTS), PULMONARY (3 PATIENTS), HEPATIC (8 PATIENTS), CEREBRAL (1 PATIENT), DELIRIUM (8 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158635 UNK KNEE STEM ATTUNE REVISION KNEE STEM JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention