INFINITY ADAPTISRecalls & reported problems across all models
Wright Medical Technology, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 219
- Deaths reported
- 0
- Injuries reported
- 214
- Recalls
- 0
We found 8 models of INFINITY ADAPTIS by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 219 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2021 and Sep 23, 2026 — classified as 214 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (80 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 ADAPTIS problems
Device problems
- Adverse Event Without Identified Device or Use Problem94
- Osseointegration Problem80
- Migration43
- Insufficient Device Problem Information32
- Fracture13
- Implant subsidence12
- Break11
- Loss of Osseointegration11
Patient problems
- Inadequate Osseointegration88
- Implant Pain48
- Insufficient Information41
- Pain35
- Cyst(s)34
- Swelling/ Edema25
- Wound Dehiscence18
- Unspecified Infection14
INFINITY ADAPTIS models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INFINITY ADAPTIS 33680013PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER53 reports
- INFINITY ADAPTIS 33680014PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER41 reports
- INFINITY ADAPTIS 33680003PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER36 reports
- INFINITY ADAPTIS 33680004PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER29 reports
- INFINITY ADAPTIS 33680001PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER21 reports
- INFINITY ADAPTIS 33680005PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER20 reports
- INFINITY ADAPTIS 33680015PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER18 reports
- INFINITY™ ADAPTIS™ 33680143PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent INFINITY ADAPTIS 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: (b)(6). Site: 200 --- (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 50865159 ↗InjuryJul 17, 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 25861748 ↗InjuryJun 17, 2026Loss of Osseointegration
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
MAUDE report 25537899 ↗InjuryJun 8, 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 MAY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis
MAUDE report 25426886 ↗InjuryMay 28, 2026Insufficient Device Problem Information
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY, HOWEVER, THE REASON FOR THE REVISION IS STILL UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 25325052 ↗InjuryMay 22, 2026Insufficient Device Problem Information
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 THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25257095 ↗InjuryMay 12, 2026Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS CURRENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 25147140 ↗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 25122287 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO PAINFUL ANKLE. NO GROSS SIGNS OF LOOSENING AND INFECTION WORKUP WAS NEGATIVE. THE PATIENT RECEIVED A CEMENT SPACER. THE PATIENT WAS SCHEDULED TO RECEIVED INVISION IMPLANTS ON (B)(6) 2026.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 25071818 ↗InjuryMay 1, 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 25057141 ↗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: (B)(6) 2025: SUBJECT CALLED THE SURGEON TO REPORT CONTINUED LEFT ANKLE PAIN AND ASKED TO PROCEED WITH A MEDIAL GUTTER DEBRIDEMENT. (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 24936001 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS FALLEN INTO VARUS AND THE PHYSICIAN WOULD LIKE TO REVISE THE TAR.
Patient problems: Malunion of Bone
MAUDE report 24744526 ↗InjuryMar 25, 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 24689319 ↗InjuryFeb 25, 2026Fracture; Loss of Osseointegration
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO PAIN, LOOSENING OF THE TIBIAL IMPLANT AS WELL AS THE BROKEN PEG.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 24447086 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
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 (B)(6) 2023. 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
Patient problems: Neuropathy; Numbness
MAUDE report 24323842 ↗
Other Wright Medical Technology, Inc. products
- INFINITY51 models · 733 reports · 3 recalls
- INBONE56 models · 365 reports · 4 recalls
- ORTHOLOC 3Di23 models · 28 reports · 2 recalls
- INFINITY BIOFOAM 3D5 models · 118 reports
- INFINITY EVERLAST20 models · 111 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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