INFINITY ADAPTIS 33680014Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00889797069694), received between Dec 9, 2021 and Jun 17, 2026 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (14 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Loss of Osseointegration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. IT WAS REPORTED: THE IMPLANTS WERE INITIALLY SIZED AND PLACED CORRECTLY, SECURED CORRECTLY WITH CEMENT BUT DID LOOSEN SLOWLY OVER THE TIMEFRAME AND BECAME MUCH MORE SYMPTOMATIC RECENTLY. THE EVENT APPEARS TO BE A STRAIGHTFORWARD CASE OF MECHANICAL LOOSENING AND SUBSEQUENT SUBSIDENCE".

  Patient problems: Inadequate Osseointegration

  MAUDE report 25537899 ↗
• 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 25325052 ↗
• InjuryMay 12, 2026Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25147140 ↗
• 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 23768139 ↗
• InjuryDec 4, 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 OF THE TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23713997 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS ANKLE (ITAR-2) STUDY. L MEDIAL ANKLE IMPINGEMENT. PERSISTENT PAIN. NARRATIVE OF ADVERSE EVENT: CONTINUED PAIN MEDIAL ANKLE AFTER TAA. PERFORMED DEBRIDEMENT (B)(6) 2022.

  Patient problems: Joint Impingement; Pain

  MAUDE report 23402211 ↗
• InjuryOct 22, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  SUBJECT: (B)(6). INFINITY WITH ADAPTIS (ITAR2) STUDY. ADVERSE EVENT: IMPLANT FAILURE RESULT DATE: (B)(6) 2025. THERE IS AN INFINITY TOTAL ANKLE WITH A PREVIOUS CALCANEAL OSTEOTOMY. THE TALAR COMPONENT IS WELL-FIXATED AND UNCHANGED COMPARED TO PREVIOUS IMAGES. HOWEVER, THE TIBIAL COMPONENT HAS A FRACTURED POSTERIOR PEG THAT WAS NOT PRESENT ON X-RAYS TAKEN 1 YEAR AGO. THERE ARE ALSO LUCENCIES ABOUT THE TIBIAL TRAY WHICH WERE PRESENT PREVIOUSLY. THIS SUGGESTS A LOOSE TIBIAL TRAY. MULTIPLE PREVIOUS X-RAYS, INCLUDING INDEX IMAGING, ARE TODAY REVIEWED AND COMPARED TO CURRENT IMAGING TO DISCERN BONY HEALING, CHANGES IN ALIGNMENT, AND OVERALL RADIOGRAPHIC STATUS. THIS REVIEW AND COMPARISON ARE INTRINSIC TO TODAY'S EVALUATION AND DECISION MAKING. ASSESSMENT THE PATIENT IS A NICE 64 Y.O., FEMALE WITH RIGHT ANKLE PAIN. DIAGNOSIS: ~3 YEARS S/P RIGHT TAR (DOS: (B)(6) 2022) DATA REVIEWED: TODAY'S XRAYS AND PREVIOUS SETS OF XRAYS. THE APPLICABLE IMAGING WAS REVIEWED WITH THE PATIENT. DISCUSSION/PLAN: THE PATIENT PRESENTS TODAY FOR HER 3-YEAR FOLLOW UP OF HER RIGHT ANKLE REPLACEMENT. SHE NOTES OCCASIONAL ACHY PAIN AS WELL AS BRUISING IN THE LATERAL ANKLE. ON PHYSICAL EXAMINATION, ANKLE MOTION IS 1

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 23355508 ↗
• InjurySep 3, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR LOOSENING OF TOTAL ANKLE REPLACEMENT COMPONENTS.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 22950210 ↗
• MalfunctionJul 29, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CENTRAL STEM ON THE TIBIAL TRAY HAS BROKEN. THE PATIENT IS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645250 ↗
• InjuryJul 2, 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 BECAUSE THE PATIENT HAD SOME PAIN AND WAS TAKEN FOR POLY SWAP/GUTTER DEBRIDEMENT AND CULTURING. THE CULTURES SHOWED INFECTION SO THE IMPLANTS WERE REMOVED. THE PATIENT RECEIVED A CEMENT ANTIBIOTIC SPACER. THE PLAN IS TO CONVERT TO INVISION SYSTEM FOLLOWING ANTIBIOTIC TREATMENT AND CLEARANCE OF ANY ACTIVE INFECTION.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 22386697 ↗
• InjuryMay 20, 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 THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO LACK OF BONEY INGROWTH IN THE TRAY. SURGEON THINKS THE FAILURE COULD BE RELATED TO THE SLOPE OF THE TIBIAL CUT.

  Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information

  MAUDE report 22056070 ↗
• InjuryMay 15, 2025Osseointegration Problem; Osseointegration 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 DUE TO ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22029786 ↗
• InjuryDec 20, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM REVIEWED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. ALL BLOODWORK, INCLUDING ALPHA DEFENSIN TESTING AND CULTURES, HAS BEEN NEGATIVE FOR INFECTION. THE PLANNED PROCEDURE INVOLVES CONVERTING THE PATIENT TO A STEMMED IMPLANT, NECESSITATING THE REMOVAL OF BOTH COMPONENTS.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 20995119 ↗
• InjuryDec 12, 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 REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20910196 ↗
• InjuryOct 28, 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). ADVERSE EVENT" DELAYED WOUND HEALING. PATIENT ARRIVES TO CLINIC WITH A WOUND TO THE ANTERIOR ANKLE. HAS BEEN TAKING ANTIBIOTICS. HAS SHOOTING PAINS UP THE ANTEROMEDIAL ANKLE. THERASKIN SKIN GRAFT WAS APPLIED IN OFFICE TO PROMOTE HEALING OF WOUND."

  Patient problems: Implant Pain; Wound Dehiscence

  MAUDE report 20543736 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: WOUND DRAINAGE. DELAYED WOUND HEALING. NOTED A VERY SMALL AREA OF DRAINAGE ON THE INCISION ANTERIOR TO ANKLE (B)(6) 2022. TOPICAL ANTIBIOTIC WAS PRESCRIBED. ON (B)(6) 2022 SMALL ESCHAR 1CM FROM WOUND WAS NOTED. DRAINAGE WAS NOTED IN (B)(6) 2022 PATIENT RECEIVED 3 WEEK COURSE OF KEFLEX AND THE GRANULOMA WAS INSPECTED. (B)(6) 2022 NO FURTHER ISSUES. DRAINAGE RESOLVED.".

  Patient problems: Wound Dehiscence

  MAUDE report 20426077 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Migration; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Migration

  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: Implant Pain; Inadequate Osseointegration; Swelling/ Edema

  MAUDE report 20395374 ↗
• 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 (B)(6) 2022: PATIENT REPORTED SWELLING HAS IMPROVED."

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 20307760 ↗
• InjurySep 25, 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) PERSISTENT PAIN. PATIENT WHO WAS 15 MONTHS OUT FROM TAA EXPRESSED DISSATISFACTION WITH POSTOPERATIVE PAIN RELIEF. POSTOPERATIVE X-RAYS AND CT DID NOT REVEAL ANY INFECTION, HARDWARE LOOSENING, POLYETHYLENE SPACER WEAR, NOR PERIPROTHESIS LUCENCY, BUT DEMONSTRATED SOME EVIDENCE OF BONY OVERGROWTH OR IMPINGEMENT TO THE MEDIAL GUTTER. PATIENT WAS THEN RECOMMENDED OPTION OF SURGERY WHICH HE ELECTED TO PROCEED WITH. REVISION SURGERY ON (B)(6) 2023 WITH REPLACEMENT OF THE POLYETHYLENE INSERT."

  Patient problems: Implant Pain; Joint Impingement

  MAUDE report 20298694 ↗
• InjurySep 10, 2024Osseointegration 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 OF THE TIBIA. THE PLAN MAY INVOLVE SWITCHING TO EITHER AN INBONE OR INVISION IMPLANT, DEPENDING ON THE CONDITION OF THE TALUS AND TIBIA.

  Patient problems: Bone Fracture(s); Cyst(s); Inadequate Osseointegration

  MAUDE report 20184932 ↗
• InjuryJun 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 LOOSE TIBIA. THERE IS SLIGHT BONE LOSS AND CYSTIC CHANGES NOTED ON CT SCANS. THE PHYSICIANS' PLANS TO REVISE BOTH THE TIBIAL AND TALAR COMPONENTS.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 19629216 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT, WHO UNDERWENT AN INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT, REPORTED STIFFNESS AND MEDIAL PAIN IN THE ANKLE DURING A CLINIC VISIT. RELIEF WAS FOUND FROM A PREVIOUS GUTTER DEBRIDEMENT PROCEDURE, BUT MEDIAL PAIN PERSISTED, EXACERBATED BY ACTIVITY. SWELLING WAS RELIEVED WITH REST AND ELEVATION. SPECT CT SCAN SHOWED INCREASED UPTAKE ALONG THE MEDIAL ANKLE AND TALUS, BUT NO IMPLANT LOOSENING WAS FOUND. TREATMENT INCLUDED CONTINUATION OF A HOME EXERCISE PROGRAM AND PRESCRIBED VOLTAREN GEL, WITH CONSIDERATION OF FUTURE MEDIAL GUTTER DEBRIDEMENT AND PLACEMENT OF A MEDIAL OSSIO SCREW. AN UPDATE INDICATED THAT THE PATIENT UNDERWENT A PLANNED OUTPATIENT PROCEDURE, INCLUDING ANKLE OPEN REDUCTION INTERNAL FIXATION MEDIAL MALLEOLUS WITH EXCISION OF MEDIAL LATERAL SPURS, GUTTER DEBRIDEMENT, AND RIGHT ANKLE SYNOVECTOMY, ADDRESSING THE PREVIOUSLY REPORTED ADVERSE EVENTS. FURTHER DETAILS WERE PENDING COMPLETION AND SIGNING OF THE OPERATIVE NOTE. IT WAS NOTED THAT THE PATIENT HAD UNDERGONE THE OUTPATIENT PROCEDURE TO ADDRESS THE ADVERSE EVENTS MENTIONED EARLIER.

  Patient problems: Implant Pain; Loss of Range of Motion; Synovitis

  MAUDE report 19105604 ↗
• InjuryFeb 26, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO TALAR IMPLANT SUBSIDENCE AND PAIN.

  Patient problems: Cyst(s); Implant Pain

  MAUDE report 18784237 ↗
• InjuryFeb 7, 2024Device Dislodged or Dislocated; Osseointegration Problem; Migration; Device Dislodged or Dislocated; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TIBIAL COMPONENT. IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED TIBIA AND DISLODGED AND MIGRATED TIBIAL COMPONENT. PATIENT CLAIMS IT WAS NOT DUE TO A FALL OR NONCOMPLIANCE. AFTER REVIEWING POST-OP X-RAYS AND CURRENT X-RAYS, THE PHYSICIAN BELIEVES PATIENT DID IN FACT FALL OR WAS NONCOMPLIANT.

  Patient problems: Cyst(s); Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 18660595 ↗
• InjuryNov 3, 2023Device Damaged by Another Device; Osseointegration Problem; Device Damaged by Another Device; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR ASEPTIC LOOSENING. THERE IS NO ATTACHMENT OF THE ANKLE REPLACEMENT COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18069995 ↗