BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE STEM TIBIAL BASE 16MM RIGHT AND LEFT

    MDR report key: 19071610 · Received April 9, 2024

    Report

    Report Number
    3010667733-2024-00191
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 10, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00840420123831
    PMA / PMN Number
    K051023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - H6 (DEVICE CODE). THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A DEVICE INSPECTION WAS PERFORMED BY GQO TEAM FOR RETURNED DEVICES AND FOLLOWING WAS OBSERVED- BOTH INBONE TIBIAL TRAY AND TIBIAL BASE WAS DETERMINED TO BE WITHIN SPECIFICATION. IT APPEARS THAT THE SURFACE DAMAGE WAS CAUSED AT THE TIME OF SURGERY/ IMPLANTATION. IT APPEARS THAT THE IMPLANT WAS OVEREXERTED DURING SURGERY/IMPLANTATION. THE SURFACE DAMAGE COULD HAVE IMPACTED HOW THE TRAY LOCKS IN. DIMENSIONALLY, EVERYTHING WAS WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, THE FAILURE IS LIKELY TO BE USER RELATED. FAILURE IS MOST LIKELY CAUSED BY APPLICATION OF HIGHER FORCE DURING IMPACTION THAT RESULTED IN SURFACE DAMAGE OF TIBIAL TRAY AND AFFECTED ITS FUNCTIONALITY. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED IT WAS REPORTED THAT TWO IMPLANTS WERE FOUND TO BE DEFECTIVE DURING A PRIMARY PROPHECY INBONE CASE. THE TIBIA FRACTURED AS A RESULT OF THE REPEATED IMPACT TO THE TIBIAL PLATE AND STEM. ARTHREX PLATES AND SCREWS WERE USED TO MANAGE THE FRACTURE AS WELL AS BONE CEMENT TO HELP FIXATE THE INBONE STEM. NEW IMPLANTS WERE USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS A 90 MINUTE DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED IT WAS REPORTED THAT TWO IMPLANTS WERE FOUND TO BE DEFECTIVE DURING A PRIMARY PROPHECY INBONE CASE. THE TIBIA FRACTURED AS A RESULT OF THE REPEATED IMPACT TO THE TIBIAL PLATE AND STEM. ARTHREX PLATES AND SCREWS WERE USED TO MANAGE THE FRACTURE AS WELL AS BONE CEMENT TO HELP FIXATE THE INBONE STEM. NEW IMPLANTS WERE USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS A 90 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270242 INBONE STEM TIBIAL BASE 16MM RIGHT AND LEFT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1763257 00840420123831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention