BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 22578785 · Received July 23, 2025

    Report

    Report Number
    1818910-2025-12743
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    February 22, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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, FIRTH AM, BERBER R, MATAR HE, JAMES PJ, BLOCH BV. REVISION RATES FOR ASEPTIC LOOSENING IN THE OBESE PATIENT: A COMPARISON BETWEEN STEMMED, UNCEMENTED, AND UNSTEMMED TIBIAL TOTAL KNEE ARTHROPLASTY COMPONENTS. ARTHROPLAST TODAY. 2025 FEB 22;32:101621. DOI: 10.1016/J.ARTD.2025.101621. ERRATUM IN: ARTHROPLAST TODAY. 2025 APR 15;33:101683. DOI: 10.1016/J.ARTD.2025.101683. PMID: 40083895; PMCID: PMC11904599. THIS RETROSPECTIVELY STUDY AIMED TO EVALUATE IMPLANT SURVIVAL FOR EXTENDED TIBIAL STEM IMPLANTS AND CEMENTLESS IMPLANTS IN COMPARISON TO CONVENTIONAL CEMENTED IMPLANTS IN HIGH BMI PATIENTS. THERE WERE 1512 KNEES THAT MET THE INCLUSION CRITERIA. PATIENTS UNDERWENT CEMENTED TKA USING A TIBIAL STEM EXTENSION (STEMMED) (N ¼ 150) AND THOSE WHERE UNCEMENTED IMPLANTS WERE USED (CEMENTLESS) (N ¼ 101) WERE COMPARED TO A CONTROL GROUP (N ¼ 1261) USING A STANDARD CEMENTED IMPLANT WITH PRIMARY ATTUNE TKAS (DEPUY, WARSAW, INDIANA). THE MEAN FOLLOW-UP WAS 6.8, 5.1, AND 5.3 YEARS FOR CEMENTED, STEMMED, AND CEMENTLESS GROUPS, RESPECTIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PRIMARY ATTUNE TKAS (DEPUY, WARSAW, INDIANA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 27). (N=14) UNDERWENT REVISIONS DUE TO INFECTION. (N=1) UNDERWENT REVISION DUE TO PERIPROSTHETIC FRACTURE. (N=1) UNDERWENT REVISION DUE TO MALALIGNMENT . (N=4) UNDERWENT REVISION DUE TO STIFFNESS. (N=6) UNDERWENT REVISION DUE TO PROGRESSIVE OA. (N=1) UNDERWENT REVISION DUE TO OTHER REASON. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE TIBIAL TRAY (QTY 6). (N=7) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING[INCLUDING (N=6) LOOSENING TIBIA]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE FEMORAL (QTY 5). (N=7) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=5) LOOSENING FEMUR]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE PATELLA (QTY 2). (N=7) UNDERWENT REVISIONS DUE TO ASEPTIC LOOSENING [INCLUDING (N=2) LOOSENING PATELLA]. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE TIBIAL INSERT (QTY 1). (N=1) UNDERWENT REVISION DUE TO IMPLANT WEAR/FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784132 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention