BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS

    MDR report key: 24323839 · Received February 12, 2026

    Report

    Report Number
    3010667733-2026-00107
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    February 24, 2023
    Report Date
    February 23, 2026
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797073066
    PMA / PMN Number
    K191393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. 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

    INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY: SUBJECT 800-001 PATIENT SENT A MESSAGE TO THE CLINICAL TEAM ON 24FEB2023 REPORTING INABILITY TO DO HEEL LIFTS DUE TO LACK OF STRENGTH. SHE ALSO REPORTED NUMBNESS THAT RUNS THE LENGTH OF HER SHIN BONE ON THE FRONT OF HER LEG. AN EMG WAS SCHEDULED 24APR2023, DUE TO PATIENT TRAVEL BEFOREHAND. EMG SHOWED EVIDENCE OF LEFT SCIATIC MONONEUROPATHY AFFECTING THE TIBIAL FASCICLES MORE THAN THE PERONEAL FASCICLES, LOCALIZED TO THE POPLITEAL FOSSA. PATIENT HAD INITIAL VISIT WITH PERIPHERAL NERVE INJURY CLINIC ON 17MAY2023. PATIENT WILL CONTINUE PHYSICAL THERAPY TO IMPROVE SYMPTOMS, MEDITECHNOLOGY CATION AND INTERVENTION WERE NOT RECOMMENDED. UPDATE (B)962026: 2025, ¿NUMBNESS AND TINGLING IN THE LEFT LEG AND FOOT HAVE IMPROVED SINCE THE LAST VISIT. SYMPTOMS ARE LIKELY DUE TO A NERVE INJURY SUSTAINED DURING THE ANKLE REPLACEMENT SURGERY THAT IS PERMANENT, THUS CLASSIFYING IT A SERIOUS ADVERSE EVENT. THE NERVE INJURY IS FOCAL, PRIMARILY AFFECTING ONE NERVE ROOT, CONTRIBUTING TO PAIN AND STIFFNESS. THE NEUROGENIC ELEMENT IS BETTER THAN BEFORE BUT NOT PERFECT. DID THIS ADVERSE EVENT MEET THE CRITERIA OF A SERIOUS ADVERSE EVENT DURING THE TIME PERIOD SINCE THE LAST REPORT? : YES¿

    Description of Event or Problem · 0

    INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY: SUBJECT (B)(6). PATIENT SENT A MESSAGE TO THE CLINICAL TEAM ON (B)(6) 2023 REPORTING INABILITY TO DO HEEL LIFTS DUE TO LACK OF STRENGTH. SHE ALSO REPORTED NUMBNESS THAT RUNS THE LENGTH OF HER SHIN BONE ON THE FRONT OF HER LEG. AN EMG WAS SCHEDULED (B)(6) 2023, DUE TO PATIENT TRAVEL BEFOREHAND. EMG SHOWED EVIDENCE OF LEFT SCIATIC MONONEUROPATHY AFFECTING THE TIBIAL FASCICLES MORE THAN THE PERONEAL FASCICLES, LOCALIZED TO THE POPLITEAL FOSSA. PATIENT HAD INITIAL VISIT WITH PERIPHERAL NERVE INJURY CLINIC ON 17MAY2023. PATIENT WILL CONTINUE PHYSICAL THERAPY TO IMPROVE SYMPTOMS, MEDICATION AND INTERVENTION WERE NOT RECOMMENDED. UPDATE 16 JAN 2026: (B)(6) 2025. ¿NUMBNESS AND TINGLING IN THE LEFT LEG AND FOOT HAVE IMPROVED SINCE THE LAST VISIT. SYMPTOMS ARE LIKELY DUE TO A NERVE INJURY SUSTAINED DURING THE ANKLE REPLACEMENT SURGERY THAT IS PERMANENT, THUS CLASSIFYING IT A SERIOUS ADVERSE EVENT. THE NERVE INJURY IS FOCAL, PRIMARILY AFFECTING ONE NERVE ROOT, CONTRIBUTING TO PAIN AND STIFFNESS. THE NEUROGENIC ELEMENT IS BETTER THAN BEFORE BUT NOT PERFECT. DID THIS ADVERSE EVENT MEET THE CRITERIA OF A SERIOUS ADVERSE EVENT DURING THE TIME PERIOD SINCE THE LAST REPORT?: YES¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385336 FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1739352 00889797073066

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other