INFINITY™ BIOFOAM™ 3D 33680033Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
Quick summary
This is a Wright Medical ankle prosthesis, an implant used to replace a damaged ankle joint. Most of the 35 reports describe the implant not growing properly into the bone, loosening, or breaking, along with pain, swelling, cysts and fractures that in some cases led to revision surgery. No deaths were reported; 32 injuries and 3 malfunctions were. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00889797073073), received between Sep 14, 2021 and May 28, 2026 — classified as 32 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (11 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 Problem12
- Osseointegration Problem11
- Fracture5
- Insufficient Device Problem Information4
- Break3
- Migration3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration13
- Cyst(s)7
- Implant Pain7
- Failure of Implant4
- Insufficient Information4
- Limb Fracture4
- Swelling/ Edema4
- Bone Fracture(s)3
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
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 25323957 ↗InjuryMar 31, 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. THE PATIENT REPORTS IMPINGEMENT PAIN BUT REMAINS ACTIVE. THE REVISION SURGERY WAS PERFORMED TO ADDRESS IMPINGEMENT.
Patient problems: Joint Impingement; Pain
MAUDE report 24743136 ↗InjuryFeb 17, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO A RUPTURED DELTOID WITH A SYNDESMOTIC FAILURE.
Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Laxity; Muscle/Tendon Damage
MAUDE report 24365265 ↗InjuryJan 27, 2026Osseointegration Problem
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO PROGRESSIVE ANTERIOR TIBIAL SUBSIDENCE AS WELL AS POSTERIOR TALAR LUCENCY CONSISTENT WITH SUBCHONDRAL CYST FORMATION DUE TO ABNORMAL ANKLE JOINT MECHANICS/PRESSURES.
Patient problems: Cyst(s)
MAUDE report 24194268 ↗InjuryDec 11, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Implant subsidence; Device Dislodged or Dislocated; Insufficient Device Problem Information; Implant subsidence
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO TALAR COMPONENT COLLAPSE AND PERIPROSTHETIC TALAR FRACTURE.
Patient problems: Limb Fracture
MAUDE report 23781928 ↗InjuryDec 4, 2025Osseointegration Problem; Osseointegration Problem
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY AS THE PATIENT HAS PAIN INDICATIVE OF EARLY LOOSENING.
Patient problems: Cyst(s); Inadequate Osseointegration; Pain
MAUDE report 23717452 ↗InjuryDec 4, 2025Fracture; Fracture
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY AS THE TALAR PEGS BROKE ON THE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 23717451 ↗InjurySep 3, 2025Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR LOOSENING OF TOTAL ANKLE REPLACEMENT COMPONENTS.
Patient problems: Cyst(s); Inadequate Osseointegration
MAUDE report 22956425 ↗InjuryJul 2, 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 UNDERWENT A DEVICE EXPLANT SURGERY BECAUSE THE PATIENT HAD SOME PAIN AND WAS TAKEN FOR POLY SWAP/GUTTER DEBRIDEMENT AND CULTURING. THE CULTURES SHOWED INFECTION SO THE IMPLANTS WERE REMOVED. THE PATIENT RECEIVED A CEMENT ANTIBIOTIC SPACER. THE PLAN IS TO CONVERT TO INVISION SYSTEM FOLLOWING ANTIBIOTIC TREATMENT AND CLEARANCE OF ANY ACTIVE INFECTION.
Patient problems: Pain; Post Operative Wound Infection
MAUDE report 22386492 ↗InjuryNov 20, 2024Adverse 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 PAIN.
Patient problems: Implant Pain
MAUDE report 20738603 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). ADVERSE EVENT" DELAYED WOUND HEALING. PATIENT ARRIVES TO CLINIC WITH A WOUND TO THE ANTERIOR ANKLE. HAS BEEN TAKING ANTIBIOTICS. HAS SHOOTING PAINS UP THE ANTEROMEDIAL ANKLE. THERASKIN SKIN GRAFT WAS APPLIED IN OFFICE TO PROMOTE HEALING OF WOUND."
Patient problems: Implant Pain; Wound Dehiscence
MAUDE report 20543752 ↗InjuryOct 2, 2024Osseointegration Problem; Osseointegration 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 DUE TO SUBSIDENCE.
Patient problems: Inadequate Osseointegration; Limb Fracture
MAUDE report 20350682 ↗InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: SUBJECT: 400-005 INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). PERSISTENT PAIN. PATIENT WHO WAS 15 MONTHS OUT FROM TAA EXPRESSED DISSATISFACTION WITH POSTOPERATIVE PAIN RELIEF. POSTOPERATIVE X-RAYS AND CT DID NOT REVEAL ANY INFECTION, HARDWARE LOOSENING, POLYETHYLENE SPACER WEAR, NOR PERIPROTHESIS LUCENCY, BUT DEMONSTRATED SOME EVIDENCE OF BONY OVERGROWTH OR IMPINGEMENT TO THE MEDIAL GUTTER. PATIENT WAS THEN RECOMMENDED OPTION OF SURGERY WHICH HE ELECTED TO PROCEED WITH. REVISION SURGERY ON (B)(6) 2023 WITH REPLACEMENT OF THE POLYETHYLENE INSERT."
Patient problems: Implant Pain; Joint Impingement
MAUDE report 20298695 ↗InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient 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. THE SURGEON IS CONSIDERING BOTH INBONE AND INVISION OPTIONS FOR THE TIBIA AND TALUS AND EXPECTS WEIGHT-BEARING FOOT AND ANKLE X-RAYS TO BE AVAILABLE SOON.
Patient problems: Insufficient Information
MAUDE report 20229586 ↗InjuryJul 18, 2024Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY BECAUSE THE TIBIAL AND TALAR COMPONENTS ARE LOOSE. THE PATIENT WAS NON-COMPLIANT AFTER SURGERY AND WEIGHT PLAYED A FACTOR.
Patient problems: Inadequate Osseointegration
MAUDE report 19778690 ↗InjuryMay 30, 2024Osseointegration Problem; Osseointegration 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 DUE TO ASEPTIC LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 19430844 ↗InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT, WHO UNDERWENT AN INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT, REPORTED STIFFNESS AND MEDIAL PAIN IN THE ANKLE DURING A CLINIC VISIT. RELIEF WAS FOUND FROM A PREVIOUS GUTTER DEBRIDEMENT PROCEDURE, BUT MEDIAL PAIN PERSISTED, EXACERBATED BY ACTIVITY. SWELLING WAS RELIEVED WITH REST AND ELEVATION. SPECT CT SCAN SHOWED INCREASED UPTAKE ALONG THE MEDIAL ANKLE AND TALUS, BUT NO IMPLANT LOOSENING WAS FOUND. TREATMENT INCLUDED CONTINUATION OF A HOME EXERCISE PROGRAM AND PRESCRIBED VOLTAREN GEL, WITH CONSIDERATION OF FUTURE MEDIAL GUTTER DEBRIDEMENT AND PLACEMENT OF A MEDIAL OSSIO SCREW. AN UPDATE INDICATED THAT THE PATIENT UNDERWENT A PLANNED OUTPATIENT PROCEDURE, INCLUDING ANKLE OPEN REDUCTION INTERNAL FIXATION MEDIAL MALLEOLUS WITH EXCISION OF MEDIAL LATERAL SPURS, GUTTER DEBRIDEMENT, AND RIGHT ANKLE SYNOVECTOMY, ADDRESSING THE PREVIOUSLY REPORTED ADVERSE EVENTS. FURTHER DETAILS WERE PENDING COMPLETION AND SIGNING OF THE OPERATIVE NOTE. IT WAS NOTED THAT THE PATIENT HAD UNDERGONE THE OUTPATIENT PROCEDURE TO ADDRESS THE ADVERSE EVENTS MENTIONED EARLIER.
Patient problems: Implant Pain; Loss of Range of Motion; Synovitis
MAUDE report 19114431 ↗InjuryApr 5, 2024Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ANTERIOR TIBIAL TRAY IMPACTING PROXIMALLY.
Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information
MAUDE report 19053869 ↗InjuryMar 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TIBIAL COMPONENT. IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED TIBIA AND DISLODGED AND MIGRATED TIBIAL COMPONENT. PATIENT CLAIMS IT WAS NOT DUE TO A FALL OR NONCOMPLIANCE. AFTER REVIEWING POST-OP X-RAYS AND CURRENT X-RAYS, THE PHYSICIAN BELIEVES PATIENT DID IN FACT FALL OR WAS NONCOMPLIANT.
Patient problems: Fall; Limb Fracture
MAUDE report 18916530 ↗InjuryFeb 26, 2024Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TIBIA COMPONENT TO INVISION TIBIA AND INBONE FLAT TOP TALUS DUE TO POOR BONE QUALITY WITH CYSTIC CHANGES IN THE TIBIA AND SUBSIDENCE WITH PAIN.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18783591 ↗InjuryFeb 2, 2024Loss of Osseointegration; Loss of Osseointegration
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TIBIAL COMPONENT DUE TO ASEPTIC LOOSENING.
Patient problems: Cyst(s); Inadequate Osseointegration
MAUDE report 18631876 ↗InjuryDec 19, 2023Migration; Migration
IT WAS REPORTED THAT THE DURING THE SIX MONTH FOLLOW UP VISIT (B)(6) 2023, EVIDENCE OF TALUS SUBSIDENCE WAS DOCUMENTED IN RADIOGRAPHIC FOLLOW-UP AND CT WAS REQUESTED. THE CT OF THE LEFT ANKLE PERFORMED ON (B)(6) 2023 WAS REVIEWED WITH PATIENT ON (B)(6) 2023 WITH FINDINGS OF FRACTURE LINES UNDER THE TALUS PROSTHESIS WITH LOSS OF TALAR HEIGHT. PHYSICAL EXAMINATION SHOWED MILD LEFT ANKLE TENDERNESS TO PALPITATION AND MODERATE SWELLING. SURGICAL INTERVENTION WAS RECOMMENDED DUE TO FAILED CONSERVATIVE MEASURES. PATIENT WILL REQUIRE REVISION TOTAL ANKLE REPLACEMENT WITH CUSTOM TALAR COMPONENT DUE TO TALUS FRACTURE LOSS OF HEIGHT. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2023 DUE TO PRESENCE OF ATRIAL FIBRILLATION DURING PREOPERATIVE WORKUP FOR LEFT ANKLE REVISION SURGERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION.
Patient problems: Bone Fracture(s); Limb Fracture; Swelling/ Edema
MAUDE report 18360458 ↗InjuryNov 3, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR ASEPTIC LOOSENING. THERE IS NO ATTACHMENT OF THE ANKLE REPLACEMENT COMPONENTS.
Patient problems: Inadequate Osseointegration
MAUDE report 18069756 ↗InjuryOct 31, 2023Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TIBIAL AND TALAR COMPONENTS DUE TO ASEPTIC LOOSENING.
Patient problems: Cyst(s); Inadequate Osseointegration
MAUDE report 18044362 ↗InjuryOct 3, 2023Migration; Migration
CLINICAL STUDY INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2): SUBJECT (B)(6) . AS REPORTED: "FRACTURE LINES UNDER TALUS PROSTHESIS WITH LOSS OF TALAR HEIGHT DURING 6 MONTH FOLLOW UP VISIT ON (B)(6) 2023, EVIDENCE OF TALUS SUBSIDENCE WAS DOCUMENTED IN RADIOGRAPHIC FOLLOW-UP AND CT WAS REQUESTED. THE CT OF THE LEFT ANKLE PERFORMED ON (B)(6) 2023 WAS REVIEWED WITH PATIENT ON (B)(6) 2023 WITH FINDINGS OF FRACTURE LINES UNDER THE TALUS PROSTHESIS WITH LOSS OF TALAR HEIGHT. PHYSICAL EXAMINATION SHOWED MILD LEFT ANKLE TENDERNESS TO PALPITATION AND MODERATE SWELLING. SURGICAL INTERVENTION WAS RECOMMENDED DUE TO FAILED CONSERVATIVE MEASURES. PATIENT WILL REQUIRE REVISION TOTAL ANKLE REPLACEMENT WITH CUSTOM TALAR COMPONENT DUE TO TALUS FRACTURE LOSS OF HEIGHT. "
Patient problems: Bone Fracture(s); Swelling/ Edema
MAUDE report 17861151 ↗
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
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.