BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT ATTUNE

    MDR report key: 20608604 · Received November 5, 2024

    Report

    Report Number
    1818910-2024-23044
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    September 8, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D2A COMMON DEVICE NAME: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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: MINODA Y, NAKAGAWA S, UEYAMA H, WARASHINA H, KATO M, MATSUMOTO T, NOZAKI M, KOBAYASHI M, HORIKOSHI Y, YASUDA J. CLINICAL OUTCOMES AND RADIOLUCENT LINE ANALYSIS IN CEMENTLESS MOBILE-BEARING TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE MULTICENTRE STUDY IN JAPAN. SCI REP. 2024 SEP 8;14(1):20902. DOI: 10.1038/S41598-024-71806-4. PMID: 39245768; PMCID: PMC11381509. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE INCIDENCE AND PROGRESSION OF RLLS AFTER CEMENTLESS TKA AND TO DETERMINE THEIR EFFECT ON CLINICAL OUTCOMES OF THE NEWLY INTRODUCED CEMENTLESS MOBILE-BEARING TKA SYSTEM (ATTUNE®) IN THE EARLY CLINICAL STAGE. SEVENTY-EIGHT PATIENTS WITH KNEE OSTEOARTHRITIS WHO UNDERWENT PRIMARY TKA WERE ENROLLED FROM JULY 2017 TO OCTOBER 2018. THERE WERE 54 FEMALES WITH MEAN AGE 70.9±5.9 YEARS. FOR SURGICAL, A NEWLY INTRODUCED CEMENTLESS MOBILE-BEARING TKA SYSTEM (ATTUNE®; DEPUY SYNTHES, INC., WARSAW, IN, USA) WAS DESIGNED TO PROVIDE ADVANCED OPTIMAL FIXATION COMPARED WITH PREVIOUS DESIGNS. 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 : CEMENTLESS MOBILE-BEARING TKA SYSTEM (ATTUNE®) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY.1) (N=1) PATIENT DEVELOPED A PROCEDURE-RELATED STAPHYLOCOCCAL INFECTION 5 DAYS AFTER THE SURGERY, WHICH RESOLVED WITH DEBRIDEMENT AND ANTIBIOTIC THERAPY WITHOUT IMPLANT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599846 UNKNOWN KNEE CONSTRUCT ATTUNE PROSTHESIS, KNEE JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention