INFINITY ADAPTIS 33680005Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889797069670), received between Oct 4, 2021 and Jul 17, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Insufficient 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 25861748 ↗
• InjuryMay 22, 2026Insufficient Device Problem Information

  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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25257095 ↗
• 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 25071818 ↗
• InjuryMar 25, 2026Insufficient 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 24689319 ↗
• 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 24071082 ↗
• InjuryDec 9, 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 MEDIAL MALLEOLAR DISTAL TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 23759408 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) INFINITY WITH ADAPTIS (ITAR2) STUDY. (B)(6) 2023: NARRATIVE OF ADVERSE EVENT: THE PATIENT IS A 64 Y.O. YEAR OLD MALE WHO IS HERE FOR FOLLOW UP OF LEFT TAR. HE REPORTS CONTINUED PARESTHESIAS AT THE DORSAL FOREFOOT AND PAIN AT THE MEDIAL ANKLE. HIS PAIN IS OVERALL BETTER COMPARED TO PRE-SURGERY. ON PE, ANKLE MOTION IS 10 DEGREES DORSIFLEXION, 40 DEGREES PLANTARFLEXION. X-RAYS SHOW THE TOTAL ANKLE PROSTHESIS APPEARS STABLE, NO EVIDENCE OF LOOSENING, FRACTURES, AND IN ACCEPTABLE ALIGNMENT. THERE APPEARS TO BE BONY IMPINGEMENT AT THE TIP OF THE MEDIAL MALLEOLUS W/ THE TALUS. I SUSPECT THAT HIS PAIN IS DUE TO MEDIAL ANKLE IMPINGEMENT. OUR NEXT STEP WOULD BE TO EITHER HAVE HIM UNDERGO A DIAGNOSTIC INJECTION OF NUMBING MEDICINE INTO THE MEDIAL ANKLE VERSUS SENDING HIM FOR A SPECT SCAN. HE ELECTS TO PROCEED W/ THE DIAGNOSTIC INJECTION. HE WAS ADVISED TO BE VERY ACTIVE DURING THE NEXT 24 HOURS AND WORK ON ANKLE PUMPS TO DETERMINE THE LEVEL OF RELIEF FROM THE INJECTION. FUTURE OPERATIVE TREATMENT WOULD CONSIST OF A MEDIAL ANKLE GUTTER DEBRIDEMENT IF THE INJECTION WERE TO PROVIDE RELIEF. INJECTION: LEFT ANKLE JOINT - AFTER INFORMED CONSENT WAS OBTAINED, THE INJECTION SITE WAS P

  Patient problems: Joint Impingement; Numbness; Pain

  MAUDE report 23355586 ↗
• 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 (B)(6) 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 21948032 ↗
• InjuryApr 7, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ASEPTIC LOOSENING AND FAILURE OF THE TIBIAL COMPONENT.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 21793472 ↗
• InjurySep 27, 2024Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 20324399 ↗
• InjuryJul 12, 2024Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; 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 19731994 ↗
• InjuryJun 26, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT'S PROSTHESIS FAILED AND WILL REQUIRE A REVISION. IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN DOING WELL UNTIL 8-10 MONTHS POST SURGERY WHEN THEY DEVELOPED INCREASING PAIN AND SWELLING. THE INFECTION WORK UP HAS BEEN NEGATIVE. UPDATE INFORMATION: BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE TREATING DOCTOR, WHO INDICATED THAT ONLY THE TIBIA COMPONENT IS LOOSE AND SEEMS TO BE THE ONLY SUSPECT DEVICE FOR THE REPORTED PAIN AND SWELLING.

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

  MAUDE report 19620370 ↗
• InjuryMar 25, 2024Loss of Osseointegration; Loss of Osseointegration

  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: Implant Pain; Inadequate Osseointegration

  MAUDE report 18967289 ↗
• MalfunctionOct 3, 2023Positioning Failure; Positioning Failure

  AS REPORTED: THE TIBIAL TRAY DOES NOT SEAT ON INSERTER. A NEW IMPLANT WAS OPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861492 ↗
• InjurySep 6, 2023Break; Fracture; Osseointegration Problem; Migration; Break; Fracture; Osseointegration Problem; Migration

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

  Patient problems: Failure of Implant; Inadequate Osseointegration; Insufficient Information

  MAUDE report 17692260 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2023 WITH STRESS REACTION, MEDIAL ANKLE. PAIN & SWELLING OVER MEDIAL SUPRAMALLEOLAR REGION. THE PATIENT DENIES INJURY OR TRAUMA. THE SYMPTOMS WERE WORSE WITH WEIGHT BEARING. THE PATIENT WAS TREATED WITH MEDICATION, BOOT AND ICE. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE PAIN IMPROVED BUT NOT COMPLETELY RESOLVED.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 17686746 ↗
• InjuryJun 8, 2023Osseointegration Problem; Osseointegration Problem

  THERE IS AN UPCOMING REVISION SURGERY DUE TO THE LOOSENING OF THE TIBIA TRAY. THE SURGEON WOULD LIKE TO TRY AND DO ANOTHER INFINITY TIBIA TRAY IF POSSIBLE IN ADDITION TO A FLAT TOP TALUS.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 17085500 ↗
• InjuryApr 14, 2023Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 16747214 ↗
• InjuryJun 9, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WILL NEED TO UNDERGO A REVISION SURGERY ON THE LEFT ANKLE DUE TO THE TIBIA COMPONENT COLLAPSING. THE PATIENT ALSO REPORTS HAVING PAIN.

  Patient problems: Implant Pain

  MAUDE report 14650618 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SPONTANEOUS INCREASE IN SWELLING AND PAIN WHICH WAS EXACERBATED 2 DAYS LATER. THE PATIENT REPORTS INCREASED SWELLING IS VERY APPARENT WHEN SHOWERING. THE SURGEON OBTAINED AN XRAY OF THE FOOT WHICH SHOWED A MEDIAL MALLEOLAR STRESS FRACTURE. PATIENT WAS PLACED IN A FRACTURE BOOT. RICE TREATMENT. 8 DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS WORSENING. THE PATIENT NOTES INCREASING PAIN AT THE MEDIAL MALLEOLUS AND FRACTURE SITE, EXACERBATED BY WEIGHT BEARING. X-RAYS TAKEN WHICH SHOW AN ABUNDANT PERIOSTEAL REACTION ABOUT THE MEDIAL MALLEOLUS FRACTURE AND INCREASED LUCENCY AT FRACTURE LINE. TOTAL ANKLE PROSTHESIS APPEARS STABLE. TREATMENT OPTIONS WERE DISCUSSED. DISCUSSED OBSERVATION WITH WBAT IN FRACTURE BOOT VS NWB WITH CRUTCHES VS SURGICAL TREATMENT. THE PATIENT UNDERWENT AN ORIF MEDIAL MALLEOLUS SIX DAYS LATER. ADVERSE EVENT IS IMPROVING. 2 WEEK FOLLOW-UP OF RIGHT MEDIAL MALLEOLUS STRESS FRACTURE S/P ORIF MEDIAL MALLEOLUS. PATIENT HAD A RIGHT ANKLE REPLACEMENT WITH DEFORMITY CORRECTION. PATIENT IS DOING WELL, MAKING EXPECTED PROGRESS AND PAIN IS WELL-CONTROLLED.

  Patient problems: Bone Fracture(s); Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12568607 ↗