INFINITY 33630025Recalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840420122063), received between May 17, 2022 and Dec 1, 2025 — classified as 11 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).
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 Problem6
- Osseointegration Problem3
- Loss of Osseointegration2
- Migration1
Patient problems
- Unspecified Infection6
- Osteolysis5
- Inadequate Osseointegration4
- Implant Pain2
- Bone Fracture(s)1
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2025Loss of Osseointegration; Loss of Osseointegration
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 2024 TO 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING - TIBIAL COMPONENT, ASEPTIC LOOSENING - TALAR COMPONENT AND PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 23687223 ↗InjuryApr 1, 2025Loss of Osseointegration; Loss of Osseointegration
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT MIGRATION/DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Inadequate Osseointegration
MAUDE report 21741696 ↗InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 UNTIL JANUARY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Implant Pain
MAUDE report 21410806 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & LYSIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20901553 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & LYSIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20901539 ↗InjuryDec 5, 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 (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, ASEPTIC LOOSENING & LYSIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection
MAUDE report 20853269 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 BETWEEN (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 20840936 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO HIGH SUSPICION (E.G. PUS OR CONFIRMED MICRO) & LYSIS OF TALUS COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20640350 ↗InjuryNov 7, 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 (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO HIGH SUSPICION (E.G. PUS OR CONFIRMED MICRO) & ASEPTIC LOOSENING OF TALAR COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20633797 ↗InjuryJul 18, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED: PATIENT REQUIRES REVISION SURGERY DUE TO PAIN AND LOOSENING OF THE TIBIA AND TALUS COMPONENTS.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19777526 ↗InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 14414339 ↗
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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