INFINITY™ BIOFOAM™ 3D 33680032Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00889797073066), received between Dec 20, 2022 and May 20, 2026 — classified as 41 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23361060 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STRYKER ITAR-2 STUDY: NARRATIVE OF ADVERSE EVENT: PATIENT REPORTED FALLING OFF A CURB ON (B)(6), 2025, RESULTING IN A CLOSED FIBULA FRACTURE OF THE RIGHT ANKLE, A SMALL TENDON TEAR OF THE RIGHT ANKLE, AS WELL AS SELF-REPORTED PAIN/DISCOMFORT OF THE LEFT ANKLE (STUDY ANKLE). RIGHT ANKLE FRACTURE TREATMENT (NON-STUDY ANKLE): THE EMERGENCY ROOM MD PLACED THE PATIENT IN A WALKING BOOT X 1 WEEK, AND AFTER FOLLOW-UP WITH AN ORTHOPAEDIC MD, THE PATIENT WAS PLACED IN AN ANKLE BRACE X 2 WEEKS AND PRESCRIBED PHYSICAL THERAPY. THE PATIENT TOOK TYLENOL PRN. RIGHT ANKLE TENDON TEAR TREATMENT (NON-STUDY ANKLE): PATIENT RETURNED TO THE ORTHOPAEDIC MD 3 MONTHS POST-FRACTURE DIAGNOSIS COMPLAINING OF CONTINUED RIGHT ANKLE PAIN. MRI SHOWED A SMALL TENDON TEAR AND THE ORIGINAL PHYSICAL THERAPY SCRIPT WAS EXTENDED TO TREAT ASSOCIATED PAIN. LEFT ANKLE SELF-REPORTED PAIN TREATMENT (STUDY ANKLE): ORTHOPAEDIC MD RECOMMENDED PHYSICAL THERAPY TO HELP STRENGTHEN THE ANKLE AND REDUCE PAIN/DISCOMFORT. AE STATUS AS OF (B)(6) 2025: BOTH RIGHT AND LEFT ANKLE PAIN ARE IMPROVING, BUT THE PATIENT CONTINUES TO GO TO PHYSICAL THERAPY. PLANNED REASSESSMENT OF THIS AE (#6) AT 2 YEAR STUDY VISIT SCHEDULED

  Patient problems: Pain

  MAUDE report 23347469 ↗
• InjurySep 26, 2025Adverse 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 OF THE TALAR COMPONENT FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23159228 ↗
• InjurySep 15, 2025Osseointegration Problem; Migration; Implant subsidence; Osseointegration Problem; Migration; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT, MALALIGNMENT, AND MIGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23057674 ↗
• InjuryAug 27, 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 THE UPCOMING REVISION SURGERY DUE TO JOINT STIFFNESS AND BONE OVERGROWTH NEAR THE IMPLANT.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 22905002 ↗
• InjuryJul 1, 2025Break; Fracture; Implant subsidence; Break; Fracture; Implant subsidence

  HE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO TALAR DOME SUBSIDENCE WITH FRACTURE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Cyst(s)

  MAUDE report 22373688 ↗
• InjuryJun 24, 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 DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22319182 ↗
• InjuryJun 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 TALAR LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22233233 ↗
• InjuryJun 6, 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 22161992 ↗
• InjuryMay 20, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22056356 ↗
• InjuryApr 1, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TALAR COMPONENT DUE TO LOOSENING. THE TIBIA APPEARS WELL FIXATED ON CT AND SPECT SCANS. THE PHYSICIAN WILL ONLY REMOVE THAT IF INTRA-OPERATIVE CELL COUNT SUGGESTS AN INFECTION.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 21740736 ↗
• InjuryMar 19, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO TIBIAL DORSAL COLLAPSE OF TIBIAL TRAY. CULTURES WILL BE TAKEN AT THE TIME OF THE REVISION TO RULE OUT ANY POSSIBLE INFECTION BEFORE REVISING.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 21647438 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 400-006 INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) PROGRESSIVE OSTEOLYTIC LESIONS (IDENTIFIED BY CT) PATIENT WHO IS 1.5 YEARS OUT FROM TAA EXPRESSES PERSISTENT PAIN. X-RAYS AND CT REVEALED CYSTIC LUCUENCY AT THE TIBIAL BONE-PROTHESIS INTERFACE, INCREASED AS COMPARED TO HIS PRIOR CT. PATIENT WAS RECOMMENDED SURGERY FOR TAA EXPLANT AND REVISION. PATIENT WISHED TO PROCEED WITH SURGERY. REVISION SURGERY WITH DEVICE EXPLANT ON (B)(6) 2024."

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20298707 ↗
• InjurySep 20, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 20273576 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6). INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). PERSISTENT PAIN ((B)(6) 2024): PATIENT REPORTED WORSENING LEFT ANKLE PAIN S/P 1 YEAR TAR. SYMPTOMS STARTED AFTER COMPLETING FORMAL PHYSICAL THERAPY AROUND THE HOLIDAYS/(B)(6) 2024. SURGEON ORDERED CT SCAN, RESULTS ARE PENDING. PERSISTENT SWELLING ((B)(6) 2024): PATIENT REPORTED WORSENING LEFT ANKLE SWELLING S/P 1 YEAR TAR. SYMPTOMS STARTED AFTER PATIENT COMPLETED FORMAL PHYSICAL THERAPY AROUND THE HOLIDAYS/(B)(6) 2024. SURGEON ORDERED A CT SCAN, RESULTS ARE PENDING.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 20240673 ↗
• InjuryJun 26, 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 UNDERWENT A REVISION. THE PATIENT HAD THE ORIGINAL SURGERY ON (B)(6) 2022 BECAUSE THE PATIENT HAD A 18 DEGREES OF VARUS AND THE PATIENT IS COMPLAINING OF PAIN.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 19618993 ↗
• InjuryJun 10, 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 WAS HAVING INCISION WOUND ISSUES AND UNDERWENT A DEVICE EXPLANT SURGERY. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Wound Dehiscence

  MAUDE report 19500040 ↗
• InjuryMay 24, 2024Insufficient 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 POSSIBLE IMPLANT LOOSENING IN ADDITION TO POSSIBLE GUTTER IMPINGEMENT. THE TALAR COMPONENT DOES APPEAR TO HAVE LOOSENING. PLAN FOR GUTTER DEBRIDEMENT AND CONSIDERATION OF IMPLANT REVISION. THE PATIENT HAS A FRACTURE PRESENT IN THE TIBIA.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 19397426 ↗
• InjuryMay 13, 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 OF BOTH TIBIAL AND TALAR IMPLANTS DUE TO PAIN AND LUCENCY.

  Patient problems: Implant Pain

  MAUDE report 19305370 ↗
• InjuryApr 13, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

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

  Patient problems: Implant Pain

  MAUDE report 19102771 ↗
• InjuryApr 9, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS DUE TO ASEPTIC LOOSENING OCCURRING LESS THAN A YEAR AFTER IMPLANTATION. NO TRAUMA, NO ABNORMAL EVENT, NO EVIDENCE OF INFECTION. PATIENT HAS RHEUMATOID ARTHRITIS AND HISTORY OF FRACTURE MANY YEARS AGO.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19076566 ↗