INFINITY 33650003Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
Quick summary
This Wright Medical Infinity total ankle replacement is a metal-and-polymer ankle joint implant used in ankle arthroplasty. The 55 reports mostly describe pain, reduced mobility, and the bone not growing into or holding the implant properly, with some loosening, bone loss around the implant, infection, and component migration, often leading to revision surgery;55 injuries and no deaths are reported. Reports fell from 29 in the earlier 12 months to 9 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00840420122506), received between Jun 4, 2021 and Mar 9, 2026 — classified as 55 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (13 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem36
- Osseointegration Problem13
- Loss of Osseointegration4
- Insufficient Device Problem Information2
- Failure to Osseointegrate1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Implant Pain13
- Inadequate Osseointegration13
- Unspecified Infection12
- Loss of Range of Motion9
- Insufficient Information8
- Osteolysis7
- Pain6
- Cyst(s)5
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Loss 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 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 LYSIS OF TIBIA, COMPONENT MIGRATION/DISSOCIATION AND STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Capsular Contracture; Osteolysis
MAUDE report 24544119 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). UK INFINITY® TOTAL ANKLE SYSTEM STUDY. PAIN AND REDUCED MOBILITY RIGHT ANKLE. NARRATIVE OF ADVERSE EVENT: AT CLINIC (B)(6) 2024 PATIEN REPORTED 3 MONTH HISTORY OF PAIN WALKING UP STAIRS AND UPHILL. AWAITING FURTHER INVESTIGATIONS CT SPECT 2025 SHOWS GUTTER IMPINGEMENT. (B)(6) 2025 ON SURGERY WAITING LIST. ADDITIONAL INFORMATION RECEIVED ON 24 MARCH 2026: ADVERSE EVENT TERM: "GUTTER IMPINGEMENT CAUSING PAIN. NARRATIVE ADDITIONAL COMMENTS: PLA IS FOR DEBRIDEMENT OF GUTTERS, EXCHANGE POYETHYLENE AND CAPSULAR DEBRIDEMENT.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 24494281 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE REVISION PROCEDURE FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24427866 ↗InjuryDec 17, 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 FOR THE MONTHLY REPORT OF NOVEMBER 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TALAR COMPONENT AND STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Loss of Range of Motion; Osteolysis
MAUDE report 23827922 ↗InjuryDec 17, 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 FOR THE MONTHLY REPORT OF (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT, LYSIS OF TIBIA, UNEXPLAINED PAIN AND STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Loss of Range of Motion; Osteolysis; Pain
MAUDE report 23827921 ↗InjuryDec 8, 2025Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO POSSIBLE LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 23750984 ↗InjuryDec 1, 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 BETWEEN JULY 2025 TO SEPTEMBER 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 17 SEP 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 23687353 ↗InjuryNov 24, 2025Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO "PAIN AND SUBSIDENCE OF TIBIAL COMPONENT. AND LOOSENING TALUS."
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 23639616 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ONGOING PAIN WITH WEIGHT BEARING AND THERE IS SOME OSTEOLYSIS BONE CYSTS UNDER THE TALAR COMPONENT.
Patient problems: Cyst(s); Osteolysis; Pain
MAUDE report 23525668 ↗InjurySep 4, 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 (B)(6) 2025 TO (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING AND LYSIS IN TIBIAL COMPONENT AND LYSIS IN TALAR COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis
MAUDE report 22963519 ↗InjuryJun 18, 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 (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Pain
MAUDE report 22282636 ↗InjuryMay 21, 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 (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Loss of Range of Motion
MAUDE report 22059650 ↗InjuryMay 16, 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 BETWEEN (B)(6) 2023 - (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION - ACTIVE , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 22038852 ↗InjuryMay 15, 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 BETWEEN (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO SOFT TISSUE IMPINGEMENT WHICH WAS NO PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Joint Impingement
MAUDE report 22030157 ↗InjuryMay 15, 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 BETWEEN (B)(6) 2024-(B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION-ACTIVE WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 22026153 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS FOR REASONS OF INFECTION.
Patient problems: Medical device site infection
MAUDE report 21927797 ↗InjuryApr 3, 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 (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, STIFFNESS AND SOFT TISSUE IMPINGEMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Capsular Contracture; Joint Impingement; Pain
MAUDE report 21764837 ↗InjuryMar 12, 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 MAY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 21585119 ↗InjuryMar 12, 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 MAY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN AND SOFT TISSUE IMPINGEMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Implant Pain; Joint Impingement
MAUDE report 21584886 ↗InjuryMar 10, 2025Osseointegration 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 REPORTED IN MARCH 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING & LYSIS OF TIBIAL COMPONENTS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. TYPE OF REVISION: STAGE 2 OF 2 STAGE REVISION.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 21566035 ↗InjuryFeb 27, 2025Osseointegration Problem; Osseointegration Problem
AS REPORTED: "SUBJECT: 300-012 STUDY: (B)(6) INFINITY TOTAL ANKLE SYSTEM POSSIBLE IMPLANT LOOSENING. X-RAY REVEALS A LUCENT LINE UNDER THE TIBIAL COMPONENT. PATIENT ADVISED TO LOWER ACTIVITY AND WE WILL SEE HIM BACK IN CLINIC IN 3 MONTHS.".
Patient problems: Inadequate Osseointegration
MAUDE report 21486088 ↗InjuryFeb 13, 2025Osseointegration 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 UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT MIGRATION /DISSOCIATION & MALALIGNMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: CONVERSION TO ARTHRODESIS
Patient problems: Failure of Implant
MAUDE report 21381950 ↗InjuryFeb 13, 2025Osseointegration 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 UNTIL FEBRUARY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.
Patient problems: Inadequate Osseointegration
MAUDE report 21381896 ↗InjuryFeb 4, 2025Osseointegration Problem; Osseointegration Problem
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR THE UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS ASEPTIC LOOSENING.
Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information
MAUDE report 21304761 ↗InjuryFeb 4, 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 BETWEEN (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Implant Pain
MAUDE report 21303201 ↗
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 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- Vantage 350-21-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 reports
- INFINITY 33600030Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.