INFINITY EVERLASTRecalls & reported problems across all models
Wright Medical Technology, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 111
- Deaths reported
- 0
- Injuries reported
- 111
- Recalls
- 0
We found 20 models of INFINITY EVERLAST by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2021 and Sep 23, 2026 — classified as 111 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported INFINITY EVERLAST problems
Device problems
- Adverse Event Without Identified Device or Use Problem96
- Osseointegration Problem10
- Insufficient Device Problem Information8
- Migration5
- Appropriate Device Problem Term/Code Not Available1
- Loss of Osseointegration1
- Material Fragmentation1
- Naturally Worn1
Patient problems
- Implant Pain26
- Pain22
- Swelling/ Edema21
- Wound Dehiscence17
- Unspecified Infection16
- Insufficient Information12
- Joint Impingement12
- Post Operative Wound Infection10
INFINITY EVERLAST models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INFINITY™ EVERLAST™ 33683206PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- INFINITY™ EVERLAST™ 33684307PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- INFINITY™ EVERLAST™ 33681108PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- INFINITY™ EVERLAST™ 33683208PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- INFINITY™ EVERLAST™ 33685407PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- INFINITY™ EVERLAST™ 33683306PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- INFINITY™ EVERLAST™ 33684406PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- INFINITY™ EVERLAST™ 33684309PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- INFINITY™ EVERLAST™ 33684408PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- INFINITY™ EVERLAST™ 33681106PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- INFINITY™ EVERLAST™ 33682208PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- INFINITY™ EVERLAST™ 33685409PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INFINITY™ EVERLAST™ 33685506PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INFINITY™ EVERLAST™ 33685508PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INFINITY™ EVERLAST™ 33682206PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INFINITY™ EVERLAST™ 33683308PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INFINITY™ EVERLAST™ 33681110PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY™ EVERLAST™ 33683212PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY™ EVERLAST™ 33684311PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY™ EVERLAST™ 33684410PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent INFINITY EVERLAST adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Study: Stryker ITAR-2.Site: (b)(6).Subject: (b)(6).Painful right total ankle replacement, four and a half years post-implantation with associated ankle pain, burning sensation, and increased numbness dorsally to the great toe.Procedure Related :Yes.Device Related: No.
Patient problems: Neuralgia; Numbness; Pain
MAUDE report 50865168 ↗InjuryJun 15, 2026Loss of Osseointegration; 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. IT WAS REPORTED: THE IMPLANTS WERE INITIALLY SIZED AND PLACED CORRECTLY, SECURED CORRECTLY WITH CEMENT BUT DID LOOSEN SLOWLY OVER THE TIMEFRAME AND BECAME MUCH MORE SYMPTOMATIC RECENTLY. THE EVENT APPEARS TO BE A STRAIGHTFORWARD CASE OF MECHANICAL LOOSENING AND SUBSEQUENT SUBSIDENCE".
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 25512609 ↗InjuryMay 28, 2026Insufficient Device Problem Information
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO POTENTIAL GUTTER ISSUES AND TIBIAL CONCERNS.
Patient problems: Insufficient Information
MAUDE report 25323456 ↗InjuryMay 19, 2026Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25222115 ↗InjuryMay 8, 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 BETWEEN 2024 -2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 25122284 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). INFINITY WITH ADAPTIS TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY. SUBJECT CALLED THE SURGEON TO REPORT CONTINUED LEFT ANKLE PAIN AND ASKED TO PROCEED WITH A MEDIAL GUTTER DEBRIDEMENT. THE SURGEON CONSIDERS THE MEDIAL GUTTER IMPINGEMENT A PROCEDURE-RELATED AE. SURGERY ON STUDY ANKLE. UPDATE ON 15 APR 2026: ON (B)(6) 2025: SUBJECT CALLED THE SURGEON TO REPORT CONTINUED LEFT ANKLE PAIN AND ASKED TO PROCEED WITH A MEDIAL GUTTER DEBRIDEMENT. ON (B)(6) 2025: SURGERY: LEFT MEDIAL TIBIAL AND MEDIAL TALUS EXOSTOSIS EXCISION FROM THE MEDIAL GUTTER OF THE ANKLE. NO PRODUCTS WERE REMOVED DURING THIS PROCEDURE.
Patient problems: Joint Impingement; Pain
MAUDE report 24936004 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT "FATIGUE FRACTURE OF THE MEDIAL MALLEOLUS AFTER TOTAL KNEE REPLACEMENT ON (b)(6) 2025, DIAGNOSED ON (b)(6), 2026. I (THE PATIENT) HAVE SUFFERED A FATIGUE FRACTURE ON THE RIGHT INNER ANKLE. I WOULD LIKE TO KNOW WHETHER THIS COMPLICATION IS KNOWN. FURTHERMORE, IN THE 13TH POSTOPERATIVE WEEK, I NOTICED SPONTANEOUS NECROSIS IN THE SCAR AREA.NOTE: AS OF (b)(6) 2026, THE ONLY X-RAYS AND IMPLANT INFORMATION PROVIDED ARE FOR AN INFINITY ANKLE."
Patient problems: Limb Fracture; Necrosis
MAUDE report 24532258 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) STUDY: (B)(6). 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 (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: 30-OCT-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 EV
Patient problems: Neuropathy; Numbness
MAUDE report 24323845 ↗InjuryJan 26, 2026Adverse 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 PERSISTENT PAIN.
Patient problems: Pain
MAUDE report 24184718 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
THE REASON FOR REVISION PERIPROSTHETIC TAR INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 24071081 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP WITH GUTTER DEBRIDEMENT.
Patient problems: Insufficient Information
MAUDE report 23927424 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO ANKLE VARUS WITH HINDFOOT PAIN AND PAIN WITH WALKING.
Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Fall; Pain
MAUDE report 23864620 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO HARDWARE FAILURE AND PAIN.
Patient problems: Pain
MAUDE report 23864012 ↗InjuryDec 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR UNKNOWN REASONS AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23770043 ↗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 JUNE 2025 TO SEPTEMBER 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS IN TALUS AND INFECTION - ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23687344 ↗
Other Wright Medical Technology, Inc. products
- INFINITY51 models · 733 reports · 3 recalls
- INBONE56 models · 365 reports · 4 recalls
- INFINITY ADAPTIS8 models · 219 reports
- ORTHOLOC 3Di23 models · 28 reports · 2 recalls
- INFINITY BIOFOAM 3D5 models · 118 reports
- EVOLVE14 models · 28 reports · 1 recall
- SWANSON12 models · 17 reports · 1 recall
- FUSEFORCE8 models · 59 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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