BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL TRAY SIGMA

    MDR report key: 23656464 · Received November 26, 2025

    Report

    Report Number
    1818910-2025-20777
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    July 24, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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. RECAPTURED CODES ON H6 (HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MAHLOULY J, WEGRZYN J, GUYEN O, DIETRICH G, MEYLAN A, ANTONIADIS A. REVISION TOTAL KNEE ARTHROPLASTY WITH CHARCOT-MARIE-TOOTH DISEASE - A CASE REPORT. INT J SURG CASE REP. 2025 SEP;134:111734. DOI: 10.1016/J.IJSCR.2025.111734. EPUB 2025 JUL 24. PMID: 40712315; PMCID: PMC12311533. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS THE CASE OF A 72-YEAR-OLD FEMALE PATIENT WITH ADVANCED CMT DISEASE WHO PRESENTED WITH TKA ASEPTIC LOOSENING ASSOCIATED WITH EXTENSIVE METAPHYSEAL BONE DEFECTS 10 YEARS AFTER INDEX SURGERY. DURING PRIMARY SURGERY, A LATERAL EPICONDYLAR SLIDING OSTEOTOMY WAS PERFORMED FOR RIGID VALGUS DEFORMITY. AN UNCONSTRAINED MOBILE BEARING IMPLANT WAS PLACED (PFC SIGMA RP-F, DEPUY ORTHOPAEDICS, WARSAW). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PFC SIGMA RP-F (DEPUY ORTHOPAEDICS, WARSAW) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED UNK KNEE CONSTRUCT SIGMA (QTY: 1): (N=1) 72-YEAR-OLD FEMALE PATIENT EXPERIENCED: PROGRESSIVELY WORSENING AND DISABLING PAIN. CORONAL AND SAGITTAL PLANE INSTABILITY. MAJOR BONE LOSS ON THE FEMUR AND TIBIA. METALLOSIS TREATMENT: ONE-STAGE REVISION TO A ROTATING-HINGE TKA (NEXGEN RHK, ZIMMER, WARSAW). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE FEMORAL SIGMA (QTY: 1): (N=1) 72-YEAR-OLD FEMALE PATIENT EXPERIENCED: -SEVERE VARUS DEFORMATION WITH A HIP-KNEE ANGLE (HKA) OF 162, PROSTHETIC LOOSENING. TREATMENT: ONE-STAGE REVISION TO A ROTATING-HINGE TKA (NEXGEN RHK, ZIMMER, WARSAW). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH KNEE TIBIAL TRAY SIGMA (QTY: 1): (N=1) 72-YEAR-OLD FEMALE PATIENT EXPERIENCED: PROSTHETIC LOOSENING, MIGRATION OF THE TIBIAL COMPONENT, SEVERE VARUS DEFORMATION WITH A HIP-KNEE ANGLE (HKA) OF 162, TREATMENT: ONE-STAGE REVISION TO A ROTATING-HINGE TKA (NEXGEN RHK, ZIMMER, WARSAW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946581 UNK KNEE TIBIAL TRAY SIGMA KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention