INFINITY BIOFOAM 3DRecalls & reported problems across all models
Wright Medical Technology, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 118
- Deaths reported
- 0
- Injuries reported
- 114
- Recalls
- 0
We found 5 models of INFINITY BIOFOAM 3D by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 118 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2021 and May 28, 2026 — classified as 114 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (29 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 BIOFOAM 3D problems
Device problems
- Adverse Event Without Identified Device or Use Problem58
- Osseointegration Problem29
- Migration17
- Insufficient Device Problem Information15
- Fracture9
- Break7
- Implant subsidence5
- Loss of Osseointegration4
Patient problems
- Inadequate Osseointegration36
- Implant Pain29
- Swelling/ Edema18
- Cyst(s)17
- Insufficient Information16
- Unspecified Infection15
- Pain14
- Failure of Implant9
INFINITY BIOFOAM 3D models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INFINITY™ BIOFOAM™ 3D 33680032PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER41 reports
- INFINITY™ BIOFOAM™ 3D 33680033PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER35 reports
- INFINITY™ BIOFOAM™ 3D 33680034PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER24 reports
- INFINITY™ BIOFOAM™ 3D 33680031PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER16 reports
- INFINITY™ BIOFOAM™ 3D 33680035PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
Recent INFINITY BIOFOAM 3D adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMay 20, 2026Device Dislodged or Dislocated
THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO TALAR COMPONENT DISLOCATION AND IMPINGEMENT ON THE FIBULA AS WELL AS TIBIAL LOOSENING.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 25230502 ↗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 25071897 ↗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 24936003 ↗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 ↗InjuryMar 20, 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. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.
Patient problems: Arthritis; Post Operative Wound Infection
MAUDE report 24654988 ↗InjuryMar 4, 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 PAIN AND DISCOMFORT OF ANKLE.
Patient problems: Discomfort; Pain
MAUDE report 24513110 ↗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 ↗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 17MAY2023. PATIENT WILL CONTINUE PHYSICAL THERAPY TO IMPROVE SYMPTOMS, MEDICATION AND INTERVENTION WERE NOT RECOMMENDED. UPDATE 16 JAN 2026: (B)(6) 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 24323839 ↗InjuryFeb 3, 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 AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24248706 ↗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 ↗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 24071096 ↗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 23864618 ↗InjuryDec 16, 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 OF THE TALAR AND TIBIAL COMPONENTS DUE TO HARDWARE FAILURE.
Patient problems: Pain
MAUDE report 23820424 ↗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 ↗
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 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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