BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INBONE TALAR STEM 10MM LG

    MDR report key: 22028600 · Received May 15, 2025

    Report

    Report Number
    3010667733-2025-00572
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 16, 2025
    Report Date
    September 19, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797030830
    PMA / PMN Number
    K051023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION - PLEASE REFER B2 OUTCOMES ATTRIBUTED TO AE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE EVALUATION OF THE RETURNED DEVICE COULD NOT RECREATE THE EVENT AND NOTHING OUT OF SPECIFICATION COULD BE IDENTIFIED. VISUAL EXAMINATION DOES NOT FIND ANY NOTICEABLE DEBRIS FOLLOWING DEVICE CLEANING. GQO SME WAS ALSO FORWARDED THE DEVICE. THE COMPLAINT PART WAS VERIFIED ON THE COMPARATOR AND NO ISSUES WERE FOUND ON THE PLASMA COATING SURFACE. THE INSPECTED PARTS MEET PRINT SPECIFICATION. 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 MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT "WHEN DR. (B)(6) WAS IMPLANTING 200347901 (10MM TALAR STEM), SHE NOTICED THAT METAL WAS COMING OFF OF THE STEM AND INTO THE PATIENT'S BONE BEFORE IMPACTING". THERE WAS A 10-MINUTE DELAY WHILE A NEW IMPLANT WAS OPENED AND ASSEMBLED. THE CASE WAS COMPLETED SUCCESSFULLY. ONCE THE STEM INSIDE THE ANKLE, THERE WAS A METAL RESIDUE THAT WAS LEFT INSIDE THE ANKLE IMMEDIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT "WHEN DR. (B)(6) WAS IMPLANTING 200347901 (10MM TALAR STEM), SHE NOTICED THAT METAL WAS COMING OFF OF THE STEM AND INTO THE PATIENT'S BONE BEFORE IMPACTING". THERE WAS A 10-MINUTE DELAY WHILE A NEW IMPLANT WAS OPENED AND ASSEMBLED. THE CASE WAS COMPLETED SUCCESSFULLY. ONCE THE STEM INSIDE THE ANKLE, THERE WAS A METAL RESIDUE THAT WAS LEFT INSIDE THE ANKLE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895904 INBONE TALAR STEM 10MM LG PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1795446 00889797030830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention