BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 21928674 · Received April 29, 2025

    Report

    Report Number
    3010667733-2025-00509
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 11, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797057141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE, PART #PROPINF, IS COMMERCIALLY AVAILABLE CLEARED 510K K131283. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. UPON FURTHER INVESTIGATION BY THE PROPHECY TEAM, THE FOLLOWING WERE NOTED: THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES, INCLUDING THE TALUS BONE MODEL. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. THE TIBIA IMPLANT AND TIBIA RESECTION WERE PROPOSED WITHIN NORMAL RANGES. NO ERRORS WERE IDENTIFIED DURING THE IMPLANT PLANNING PROCEDURE. THE ALIGNMENT GUIDES WERE DESIGNED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. THE ENGINEERING DRAWINGS AND QUALITY DOCUMENTS WERE PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE UNEXPECTED ANTERIOR SLOPE OF THE TIBIA CUT AND THE DIFFERENCE BETWEEN THE PROPHECY TALUS BONE MODEL AND THE PATIENT¿S TALUS ANATOMY. A POTENTIAL ROOT CAUSE MAY BE A DISCREPANCY IN USER EXPECTATIONS VS GUIDE FIT AND FEEL INTRAOPERATIVELY, OR USER ERROR DURING SURGERY. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUTTING GUIDE DOES NOT MATCH THE PATIENT'S ANATOMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUTTING GUIDE DOES NOT MATCH THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428071 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1813968 00889797057141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown