INFINITY™ BIOFOAM™ 3D 33680034Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889797073080), received between Mar 15, 2022 and May 4, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 10, 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 UNKNOWN REASONS AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23769036 ↗
• InjuryNov 20, 2025Loss of Osseointegration; Implant subsidence; Loss of Osseointegration; Implant subsidence

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY DUE TO THE TALAR COMPONENT FALLING IN VARUS.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 23611927 ↗
• InjurySep 25, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT REVISION SURGERY MAY BE REQUIRED. A TOTAL ANKLE REPLACEMENT WITH A WRIGHT MEDICAL/STRYKER DEVICE WAS PREVIOUSLY PERFORMED FOR ARTHRITIS AND ANKLE PAIN. REPORTS INCLUDE SWELLING AND MEDIAL ANKLE PAIN, WITH IMAGING SUGGESTING A POSSIBLE MEDIAL MALLEOLUS STRESS FRACTURE AND POTENTIAL TIBIAL TRAY LOOSENING. NO REVISION HAS BEEN PERFORMED TO DATE. BONE QUALITY WAS DESCRIBED AS GOOD, AND COMPLIANCE WITH MOBILIZATION INSTRUCTIONS WAS NOTED, THOUGH A PHYSICALLY ACTIVE LIFESTYLE MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOMS.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 23142539 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: (B)(4). SUBJECT: (B)(6). INFECTION, DEEP PATIENT CAME IN FOR 2-YR FOLLOW UP ON MAR 13 AND HAD BEEN DOING VERY CLINICALLY WELL UNTIL THAT POINT. STARTING (B)(6), PATIENT STARTED EXPERIENCING SYMPTOMS OF PAIN, REDNESS, AND SWELLING IN AND AROUND THE STUDY ANKLE, FEVER AS WELL FOLLOWING SEVERAL DENTAL PROCEDURES. WORKUP SHOWED INCREASED INFLAMMATORY MARKERS AND AN MRI SUSPICION OF INFECTION AROUND THE ANTERIOR TIBIAL TENDON. PRESUMED IT WAS DEEP ALSO BECAUSE OF THE PROXIMITY OF THE IMPLANT. EXPLAINED RISK AND BENEFITS OF THE RATIONALE FOR URGENT BASED SURGERY TO DO AN I&D AND RETAIN THE PROSTHESIS BUT EXCHANGE THE POLYETHYLENE."

  Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21948036 ↗
• InjuryApr 16, 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 MAY REQUIRE REVISION SURGERY DUE TO AN INFECTION. THE WOUND REPORTEDLY DEVELOPED IN LATE (B)(6) OR EARLY (B)(6). NOTABLY, FOOT DROP RELATED TO A PREOPERATIVE NERVE BLOCK WAS IDENTIFIED AS A REMARKABLE CIRCUMSTANCE IN THIS EVENT. A REVISION SURGERY IS PLANNED FOR MID TO LATE (B)(6).

  Patient problems: Loss of Range of Motion; Nerve Damage; Post Operative Wound Infection

  MAUDE report 21852177 ↗
• InjuryFeb 26, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF TIBIAL COMPONENT FOR REASONS OF LOOSE TIBIAL TRAY AND ASEPTIC LOOSENING OF THE TIBIA WITH ONGOING PAIN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21475051 ↗
• InjuryJan 8, 2025Implant subsidence; Implant subsidence

  AS REPORTED: "CLINICAL STUDY INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2): SUBJECT: (B)(6). IMPLANT SUBSIDENCE. PATIENT UNDERWENT SURGERY ON (B)(6) 2024, ANKLE TIBIOTALAR CALCANEAL ARTHRODESIS PLACEMENT CUSTOM CAGE, ALLOGRAFT ANKLE HARDWARE REMOVAL TO ADDRESS IMPLANT SUBSIDENCE DOCUMENTED."

  Patient problems: Osteolysis

  MAUDE report 21100513 ↗
• InjuryOct 8, 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 REQUIRE A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS DUE TO SWELLING AND PAIN.

  Patient problems: Cyst(s); Implant Pain; Swelling/ Edema

  MAUDE report 20395375 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ADAPTIS SUBJECT (B)(6) PATIENT PRESENTED TO CLINIC ON (B)(6) 2022 (5 WEEKS AND 5 DAYS S/P LEFT TAR PROCEDURE), C/O PLANTAR NUMBNESS AND DIFFICULTY WITH TOE FLEXION. UPON EXAM, THE SURGEON CONFIRMED SUPERFICIAL AND PERONEAL NERVES ARE INTACT. SURAL NERVE IS INTACT. THE SURGEON ORDERED AN EMG; (B)(6) 2022 EMG REPORT/CLINICAL IMPRESSION: PATIENT HAS COMPRESSIVE NEUROPATHY AT LEFT TARSAL TUNNEL AND FIBULAR HEAD, DUE TO POSTOP SWELLING, CASTING, AND THE BOOT. F/U PENDING. UPDATE (B)(6) 2023: PATIENT CONTINUES TO HAVE TIBIAL NERVE IRRITATION. THE SURGEON DOES NOT BELIEVE THIS EVENT IS DUE TO A TRAUMATIC TIBIAL NERVE LACERATION DURING TAR PROCEDURE, BUT RESIDUAL IRRITATION FROM THE NERVE BLOCK OR SWELLING."

  Patient problems: Loss of Range of Motion; Neuropathy; Numbness; Swelling/ Edema

  MAUDE report 20307762 ↗
• InjurySep 26, 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) PATIENT PRESENTED TO THE CLINIC FOR A POSTOP FOLLOW UP APPOINTMENT ON (B)(6) 2022 (3 MONTHS S/P LEFT TAR PROCEDURE), CONCERNED ABOUT CONTINUED SIGNIFICANT SWELLING AND DISCOMFORT. THE SURGEON ORDERED AN ULTRASOUND TO RULE OUT A LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) ON (B)(6) 2022. ULTRASOUND REPORT FOUND NO EVIDENCE OF A DVT. PATIENT IS SCHEDULED FOR ANOTHER POSTOP VISIT ON (B)(6) 2022 (6 MONTHS S/P LEFT TAR PROCEDURE). UPDATE 08 DEC 2022: PATIENT REPORTED SWELLING HAS IMPROVED."

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 20307752 ↗
• InjuryJul 24, 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 UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 19820217 ↗
• InjuryJun 25, 2024Unintended Movement; Unintended Movement

  AS REPORTED: "ADVERSE EVENT: IMPLANT FAILURE. NARRATIVE OF ADVERSE EVENT: IMPLANT FAILED. LOOSENING AND SUBSIDENCE WAS NOTICED ON IMAGING POST-OP ON (B)(6) 2024. IT NEEDS TO BE REMOVED AND REPLACED." REVISION SURGERY WAS PERFORMED ON (B)(6) 2024."

  Patient problems: Failure of Implant

  MAUDE report 19608215 ↗
• InjuryMay 31, 2024Osseointegration Problem; Osseointegration Problem

  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 LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19436346 ↗
• InjuryApr 24, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH COMPLAINTS OF PAIN AND SWELLING ON THE LEFT ANKLE. UPON PHYSICAL EXAMINATION SHOWED MEDIAL LATERAL LEFT ANKLE TENDERNESS TO PALPITATION WITH MID LEFT ANKLE SWELLING. THE ANTERIOR WOUND IS WELL-HEALED WITH NO ERYTHEMA OR SIGN OF INFECTION. X-RAYS REVIEWED INDICATED THAT THERE MAY SOME TALAR SUBSIDENCE AND LOOSENING. NO OBVIOUS FRACTURES WERE EVIDENT. IT WAS RECOMMEND THAT THE PATIENT CONTINUE HOME EXERCISE PROGRAM AND USE PRESCRIBED VOLTAREN GEL. A SPECT CT WAS ORDERED TO EVALUATE ANY LOOSING IN SUBSIDENCE.

  Patient problems: Implant Pain; Inadequate Osseointegration; Swelling/ Edema

  MAUDE report 19176437 ↗
• InjuryFeb 27, 2024Migration; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSE INFINITY TIBIAL COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 18790594 ↗
• InjuryJan 18, 2024Break; Positioning Failure; Fracture; Loss of Osseointegration; Migration; Break; Positioning Failure; Fracture; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A 1 YEAR FOLLOW UP. UPON REVIEW OF THE CASE THE PHYSICIAN NOTICED THAT THE POSTERIOR PEG OF THE TALAR COMPONENT IS BROKEN AND IS NOT FULLY SEATED UPON IMPLANTATION. THE PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: Cyst(s); Failure of Implant; Inadequate Osseointegration

  MAUDE report 18537720 ↗
• InjuryNov 2, 2023Osseointegration 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 18062215 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2): SUBJECT (B)(6) . AS REPORTED: "LEFT ANKLE PAIN, SWELLING, AND NUMBNESS PATIENT WAS SEEN FOR 3 MONTH FOLLOW UP OF LEFT ANKLE ON (B)(6) 2023 WITH COMPLAINTS OF PAIN, SWELLING, AND NUMBNESS SINCE LAST VISIT ON (B)(6) 2023. MOST OF THE PAIN WAS REPORTED OUTSIDE ASPECT OF ANKLE. EXAMINATION SHOWED WELL-HEALED SCAR WITH TENDERNESS OF LEFT SUBTALAR JOINT WITH MINIMAL DISCOMFORT LATERAL ASPECT OF THE ANKLE. RADIOGRAPHIC IMAGING SHOWED NO EVIDENCE OF LUCENCY. AROUND THE HARDWARE. PATIENT IS TO CONTINUE WEARING BOOT, PHYSICAL THERAPY, USE VOLTAREN GEL, AND STABILIZE THE ANKLE WITH PRESCRIBED LACE-UP ANKLE BRACE."

  Patient problems: Discomfort; Implant Pain; Numbness; Swelling/ Edema

  MAUDE report 17864740 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION DUE TO PAIN, RESULTING IN THE REMOVAL OF ALL PRIMARY TAA IMPLANTS AND THE PLACEMENT OF A CEMENT SPACER.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 17660322 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A 6 MONTH POST OP VISIT AND REPORTED CONTINUED RIGHT ANKLE PAIN, MOSTLY ABOUT THE ANTERIOR ANKLE JOINT. PATIENT IS UNABLE TO DORSIFLEX PAST NEUTRAL AND HAS TROUBLE MAINTAINING A NORMAL GAIT PATTERN. ACTIONS TAKEN TO RESOLVE THIS WERE MEDICATION (UNKNOWN), ROCKER-BOTTOM SHOES AND USE OF A COMPRESSION SOCK AT WORK.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Loss of Range of Motion

  MAUDE report 17313127 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2022, CONCERNED ABOUT AN INFECTION OF THE ANTERIOR ANKLE INCISION. THE PHYSICIAN NOTED A SURGICAL WOUND COMPLICATED BY DEHISCENCE, DRAINAGE OF PURULENT FLUID, SWELLING, AND ERYTHEMA. FOLLOWING A RIGHT ANKLE WOUND IRRIGATION AND DEBRIDEMENT ON (B)(6) 2022, THE PHYSICIAN NOTED NO EVIDENCE OF A DEEP INFECTION. ROUTINE CULTURE FINAL REPORT ON (B)(6) 2022, CONFIRMED A STAPHYLOCOCCUS AUREUS INFECTION. PATIENT WAS PRESCRIBED KEFLEX.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 15463627 ↗
• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT ANKLE HARDWARE REMOVAL AND LEFT REVISION TOTAL ANKLE REPLACEMENT WITH POSSIBLE COLLATERAL LIGAMENT REPAIR WITH INTERNAL BRACE AND LEFT ACHILLES TENDON LENGTHENING ALL ON THE LEFT. THE PATIENT IS STATUS POST LEFT ANKLE REPLACEMENT 2019 BUT CONTINUES TO DEVELOP ARTHRITIS CHANGES PARTICULAR ALONG THE MEDIAL AND LATERAL GUTTER ALONG WITH PAIN AND REDUCED RANGE OF MOTION. THE PATIENT ALSO HAS SOME LOOSENING OF IMPLANT ON IMAGING. THE PATIENT ELECTED FOR REVISION REPLACEMENT WITH LARGER IMPLANT AND IS SCHEDULED FOR SURGERY (B)(6) 2021. THE REPORTS OVERALL HE IS DOING OK. HE REMAINS FOLLOWED WITH RHEUMATOLOGY FOR HIS RA WHICH HAS BEEN WELL CONTROLLED ON XELJANZ.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Loss of Range of Motion; Rheumatoid Arthritis

  MAUDE report 13776076 ↗