INFINITY™ BIOFOAM™ 3D 33680031Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889797073059), received between Aug 30, 2021 and Mar 20, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• InjurySep 17, 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 IMPLANT LOOSENING, WITH CONSIDERATION FOR A GUTTER AND POLY SWAP.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 23077215 ↗
• InjuryJun 6, 2025Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; 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 BECAUSE IT LOOKS LIKE THE BONE DID NOT SUPPORT THE INFINITY AND STEMMED IMPLANT IS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 22160389 ↗
• InjuryApr 1, 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 REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 21748611 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER ITAR-2 SUBJECT: (B)(6). DURING 2Y FOLLOW-UP VISIT ON (B)(6) 2024, SUBJECT REPORTED INCREASING PAIN AND SWELLING TO THE INSIDE ASPECT OF THE LEFT ANKLE. MUSCULOSKELETAL EXAM INDICATED DIFFUSE TENDERNESS TO THE MEDIAL REGION OF THE LEFT ANKLE AND SIGNIFICANT DISCOMFORT TO THE MEDIAL GUTTER. IMAGING RESULTS SHOWED A STABLE APPEARING LEFT TOTAL ANKLE REPLACEMENT WITH NO LUCENCY AROUND THE HARDWARE. POSSIBLE IMPINGEMENT OF THE MEDIAL GUTTER WAS NOTED. SUBJECT WILL CONTINUE TO FOLLOW-UP WITH SURGEON AND IF PAIN CONTINUES THE PATIENT COULD REQUIRE MEDIAL GUTTER DEBRIDEMENT OR POSSIBLY A SPECT CT SCAN. SUBJECT WAS PRESCRIBED MELOXICAM FOR PAIN.

  Patient problems: Discomfort; Implant Pain; Joint Impingement; Swelling/ Edema

  MAUDE report 21035642 ↗
• InjuryNov 5, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO TALAR SUBSIDENCE AND PAIN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20615018 ↗
• InjuryAug 26, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO PATIENT HAVING PAIN AND POSSIBLE LOOSENING. THE PLAN IS TO EITHER FUSE OR REVISE WITH INVISION INBONE SYSTEM.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20071864 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DELAYED WOUND HEALING AT ANTERIOR ANKLE INCISION. TREATMENT INCLUDES ORAL ANTIBIOTICS AND KEEPING INCISION COVERED AND DRY. ON (B)(6) 2023, THERE WAS SLIGHT IMPROVEMENT OF THE INCISION SINCE PREVIOUS VISIT, HOWEVER, DELAYED HEALING WAS STILL PRESENT. ON (B)(6) 2023, IT WAS NOTED THAT THERE WAS DELAYED WOUND HEALING IMPROVING WITH OUTPATIENT WOUND CARE.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 18022630 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION FOR REASONS CURRENTLY UNKNOW. THE PLAN IS TO PROCEED WITH THE INVISION CASE IN THE NEAR FUTURE. TALAR SUBSIDENCE IS NOTED AS AN ISSUE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 17660464 ↗
• InjuryAug 23, 2023Migration; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH TIBIAL AND TALAR COMPONENTS DUE TO SUSPECTED SUBSIDENCE. IT WAS ALSO REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN, DISCOMFORT AND SWELLING.

  Patient problems: Discomfort; Implant Pain; Swelling/ Edema

  MAUDE report 17606508 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT THAT THERE IS AN UPCOMING REVISION SURGERY DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17410433 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT AS JUST UNDER 2 WEEKS OUT FROM TOTAL ANKLE REPLACEMENT WITH MEDIAL MALL SCREW. THE PATIENT CAME IN FOR ROUTINE POSTOP VISIT ON(B)(6) 2022. IT WAS NOTED UPON WOUND INSPECTION THAT THERE WAS SOME DRAINAGE FROM THE MEDIAL WOUND. UPON PALPATION THERE WAS A FRANK PURULENCE. BECAUSE OF THIS, INDICATED FOR I&D. AN MRI SHOWED SOME POSSIBLE CONNECTION OF THE FLUID MEDIALLY ALONG WITH OUT OF THE ANTERIOR TIBIA ALONG THE SIDE OF THE IMPLANT. THE PATIENT HAS BEEN ON IV ANTIBIOTIC THERAPY WITH ROCEPHIN AND DAPTOMYCIN. THE PATIENT IS KEEPING THE FOOL ELEVATED, HAS BEEN NON-WEIGHT BEARING IN A SPLINT AND TAKING A BABY ASPIRIN TWICE DAILY FOR DVT PROPHYLAXIS. THE PAIN IS WELL CONTROLLED AND THE INFECTION IS IMPROVING.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 16018781 ↗
• InjuryAug 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TALAR DOME FAILED. VOIDS WERE NOTICED UNDER THE TALAR DOME.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 12385762 ↗