INFINITY 33652208Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
All models of INFINITY (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840420122636), received between Dec 8, 2021 and Jul 8, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Osseointegration Problem1
Patient problems
- Pain3
- Discomfort2
- Implant Pain2
- Cyst(s)1
- Extraskeletal ossification1
- Inadequate Osseointegration1
- Swelling/ Edema1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) UK INFINITY TOTAL ANKLE SYSTEM STUDY. DISCOMFORT/TENDERNESS MEDICAL ASPECT OF ANKLE (RIGHT). PATIENT EXPERIENCING DISCOMFORT/TENDERNESS, INFORMED BY HER PHYSIOTHERAPIST THAT IT COULD BE TENDON RELATED. USING CRUTCHES TO MOBILIZE AND FINDING IT UNCOMFORTABLE TO GET UP FROM SITTING. PATIENT DISCUSSING WITH HER CONSULTANT. PROCEDURE RELATED: YES.
Patient problems: Discomfort; Pain
MAUDE report 25746058 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Pain
MAUDE report 24543938 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "STUDY: UK INFINITY® TOTAL ANKLE SYSTEM. SUBJECT: (B)(6). DISCOMFORT TO ANTEROMEDIAL ASPECT OF RIGHT ANKLE JOINT THAT RADIATES UP THE LEG. X-RAYS SHOW BONE FORMATION AT THE FRONT OF THE JOINT. LISTED FOR EXPLORATION OF THE ANTEROMEDIAL ASPECT OF THE RIGHT ANKLE JOINT AND REMOVAL OF BONY FORMATION."
Patient problems: Discomfort; Extraskeletal ossification; Pain
MAUDE report 21966503 ↗InjuryOct 10, 2024Osseointegration Problem; Osseointegration Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 21 JANUARY, 2019 A PATIENT REQUIRED REVISION DUE TO ASEPTIC LOOSENING - TIBIAL COMPONENT , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Inadequate Osseointegration
MAUDE report 20417760 ↗InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO INCREASED PAIN AND SWELLING 6-8 MONTHS POST-OP. THE PATIENT'S INFECTION WORK UP HAS BEEN NEGATIVE.
Patient problems: Cyst(s); Implant Pain; Swelling/ Edema
MAUDE report 19635572 ↗InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE PAIN IN THE ANKLE FOLLOWING THE SURGERY. CT SHOWED NO EVIDENCE OF SIGNIFICANT LOOSENING OF THE IMPLANTS. SUSPECT BONY IMPINGEMENT AS LIKELY CAUSE OF PAIN. PATIENT ALSO NOTED TO HAVE END-STAGE TALONAVICULAR ARTHRITIS. REVISION SURGERY TOOK PLACE TO REVISE ANKLE IMPLANT WITH POLY EXCHANGE AND GUTTER CLEANOUT, TALONAVICULAR JOINT FUSION WITH CALCANEUS BONE GRAFT HARVEST. SUBJECT CONTINUING TO IMPROVE SINCE POLY EXCHANGE SURGERY, FOLLOW-UP YEARLY.
Patient problems: Implant Pain
MAUDE report 12964552 ↗
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- INFINITY 33600030Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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