BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE TIBIAL TRAY

    MDR report key: 20078850 · Received August 27, 2024

    Report

    Report Number
    1818910-2024-18174
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 3, 2024
    Report Date
    August 27, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: VAN DUREN BH, FRANCE J, BERBER R, MATAR HE, JAMES PJ, BLOCH BV. IS THERE AN INCREASED REVISION RATE DUE TO EARLY TIBIAL COMPONENT LOOSENING WITH A MODERN TOTAL KNEE ARTHROPLASTY DESIGN? A RETROSPECTIVE ANALYSIS FROM A LARGE VOLUME ARTHROPLASTY CENTRE. ARTHROPLASTY. 2024 AUG 3;6(1):46. DOI: 10.1186/S42836-024-00264-0. PMID: 39095924; PMCID: PMC11297728. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: VAN DUREN BH, FRANCE J, BERBER R, MATAR HE, JAMES PJ, BLOCH BV. IS THERE AN INCREASED REVISION RATE DUE TO EARLY TIBIAL COMPONENT LOOSENING WITH A MODERN TOTAL KNEE ARTHROPLASTY DESIGN? A RETROSPECTIVE ANALYSIS FROM A LARGE VOLUME ARTHROPLASTY CENTRE. ARTHROPLASTY. 2024 AUG 3;6(1):46. DOI: 10.1186/S42836-024-00264-0. PMID: 39095924; PMCID: PMC11297728. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO EVALUATE THE OVERALL REVISION RATES AND THOSE SPECIFIC TO ASEPTIC LOOSENING OF THE NOVEL IMPLANT DESIGN IN COMPARISON TO AN ESTABLISHED PREDICATE AS WELL AS TO ALL OTHER IMPLANT DESIGNS USED IN THIS HIGH-VOLUME ARTHROPLASTY CENTER. BETWEEN 1ST APRIL 2003 AND 31ST MARCH 2022, A TOTAL OF 10,202 PATIENTS WHO UNDERWENT PRIMARY CEMENTED TKA WITH A MINIMUM OF 1 YEAR FOLLOW-UP WERE INCLUDED IN THE STUDY. AMONG THESE, 2406 PATIENTS (1463 WERE FEMALES) HAD ATTUNE TKR (557 S+ AND 1849 STANDARD), 4642 PATIENTS (2681 WERE FEMALES) HAD PFC SIGMA TKR, 3154 HAD OTHER DESIGNS (ALL COMPETITORS). A SINGLE-STAGE CEMENTING TECHNIQUE WAS USED BY EMPLOYING EITHER PALACOS R+ G (HERAEUS MEDICAL, HANAU, GERMANY) OR SMARTSET GHV (DEPUY SYNTHES, WARSAW, IN, USA) VACUUM-MIXED CEMENT. CEMENT WAS APPLIED TO BOTH BONE AND IMPLANT CONTACT SURFACES. MEAN FOLLOW-UP WAS 5.3, 9.1, AND 9.9 YEARS FOR THE ATTUNE, PFC, AND ALL OTHER IMPLANT GROUPS RESPECTIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES ATTUNE AND PFC SIGMA OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: PALACOS R+ G (HERAEUS MEDICAL) OR SMARTSET GHV CEMENT (DEPUY SYNTHES) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY (B)(4): (N=29) UNDERWENT REVISIONS DUE TO (N=6) INFECTION, (N=2) PERIPROSTHETIC FRACTURE, (N=3) INSTABILITY, (N=1) MALALIGNMENT, (N=5) STIFFNESS, (N=10) PROGRESSIVE OSTEOARTHRITIS, AND (N=2) OTHER REASONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE TIBIAL TRAY (QTY 7): (N=9) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=7) LOOSENING TIBIA]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE FEMORAL (QTY 6): (N=9) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=6) LOOSENING FEMUR]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE PATELLA (QTY 2): (N=9) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=2) LOOSENING PATELLA]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT SIGMA (QTY (B)(4): (N=108) UNDERWENT REVISIONS DUE TO (N=20) PAIN, (N=36) INFECTION, (N=6) PERIPROSTHETIC FRACTURE, (N=17) INSTABILITY, (N=6) MALALIGNMENT, (N=5) STIFFNESS, (N=8) PROGRESSIVE OSTEOARTHRITIS, AND (N=10) OTHER REASONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL TRAY SIGMA (QTY (B)(4); (N=22) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=13) LOOSENING TIBIA]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE FEMORAL SIGMA (QTY 7): (N=22) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=6) LOOSENING FEMUR]. (N=1) UNDERWENT REVISIONS DUE TO DISLOCATION/SUBLUXATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE PATELLA SIGMA (QTY 8): (N=22) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=6) LOOSENING PATELLA]. (N=2) UNDERWENT REVISIONS DUE TO IMPLANT WEAR/FRACTURE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL INSERT SIGMA (QTY 3): (N=1) UNDERWENT REVISIONS DUE TO DISLOCATION/SUBLUXATION. (N=2) UNDERWENT REVISIONS DUE TO IMPLANT WEAR/FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479546 UNK ATTUNE KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN CEMENT