BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE STEM TIBIAL BASE 16MM RIGHT AND LEFT

    MDR report key: 21392568 · Received February 18, 2025

    Report

    Report Number
    3010667733-2025-00168
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 21, 2025
    Report Date
    June 4, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00840420123831
    PMA / PMN Number
    K051023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4 (GTIN) AND G1 (REPORTING CONTACT). THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OTHER EVIDENCE WAS PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED CURRENTLY. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATION OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. HOWEVER, AS PATIENT ALLEGED THE ALLERGIC REACTION WITH IMPLANT, IT HAS BEEN STATED IN IFU SECTION F ¿ ADVERSE EFFECTS THAT 2. ALTHOUGH RARE, METAL SENSITIVITY REACTIONS IN PATIENTS FOLLOWING JOINT REPLACEMENT HAVE BEEN REPORTED. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES CAN RESULT IN HISTOLOGICAL REACTIONS INVOLVING PRODUCTION OF MACROPHAGES AND FIBROBLASTS. 6.INFECTION CAN LEAD TO FAILURE OF JOINT REPLACEMENT. 9.ALLERGIC REACTIONS TO PROSTHETIC COMPONENT MATERIAL CAN OCCUR. THE DEVICE IS MADE FROM A MEDICAL GRADE TITANIUM ALLOY AND CERAMICS IS NOT USED. MICROBIOLOGISTS REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING, BIOBURDEN DATA AND DHR AND NOTED THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATION FOR A NON-CONFORMANCE COULD BE FOUND. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPERIENCING A SEVERE ALLERGIC REACTION AND INFECTION RELATED TO THE METAL COMPONENTS IN A STRYKER PRODUCT. THEY ALSO ALLEGE CHRONIC FOOT PAIN CAUSED BY THE IMPLANTS AND HAVE REQUESTED AN ANKLE AMPUTATION, STATING THEY DO NOT BELIEVE THEY ARE A SUITABLE CANDIDATE FOR AN ANKLE PROSTHESIS. POSTOPERATIVELY, THE PATIENT¿S PRIMARY CARE PHYSICIAN EXAMINED THE ANKLE AND NOTED SIGNS CONSISTENT WITH INFECTION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIBIOTICS. DURING A FOLLOW-UP WITH THE SURGEON, THEY WERE ADVISED TO USE NUMBER TWO COMPRESSION SOCKS. THE PATIENT IS CURRENTLY SEEKING ADDITIONAL MEDICAL OPINIONS REGARDING NEXT STEPS AND HAS MENTIONED IDENTIFYING A SURGEON WHO MAY BE ABLE TO PERFORM THE ANKLE AMPUTATION.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPERIENCING A SEVERE ALLERGIC REACTION AND INFECTION RELATED TO THE METAL COMPONENTS IN A STRYKER PRODUCT. THEY ALSO ALLEGE CHRONIC FOOT PAIN CAUSED BY THE IMPLANTS AND HAVE REQUESTED AN ANKLE AMPUTATION, STATING THEY DO NOT BELIEVE THEY ARE A SUITABLE CANDIDATE FOR AN ANKLE PROSTHESIS. POSTOPERATIVELY, THE PATIENT¿S PRIMARY CARE PHYSICIAN EXAMINED THE ANKLE AND NOTED SIGNS CONSISTENT WITH INFECTION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIBIOTICS. DURING A FOLLOW-UP WITH THE SURGEON, THEY WERE ADVISED TO USE NUMBER TWO COMPRESSION SOCKS. THE PATIENT IS CURRENTLY SEEKING ADDITIONAL MEDICAL OPINIONS REGARDING NEXT STEPS AND HAS MENTIONED IDENTIFYING A SURGEON WHO MAY BE ABLE TO PERFORM THE ANKLE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982943 INBONE STEM TIBIAL BASE 16MM RIGHT AND LEFT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1788814 00840420123831

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other