INFINITY™ 33680021 (UDI 00889797101516)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889797101516), received between Sep 2, 2021 and Jul 21, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 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. PLAN IS TO REVISE TIBIA (IF NEEDED) AND TALUS FOR CERTAIN.

  Patient problems: Insufficient Information

  MAUDE report 25897294 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. PROGRESSIVE PERIPROSTHETIC CYSTS. LARGE TALAR CYST ADJACENT TO TALAR IMPLANT ON THE RIGHT ANKLE. REVISION SURGERY WITH POLYETHYLENE COMPONENT REMOVAL PARFORMED ON (B)(6) 2026.

  Patient problems: Cyst(s)

  MAUDE report 25810895 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2024: PATIENT IMPROVING 4 WEEKS POST OP AND SITE IS HEALING. (B)(6) 2024: MOST RECENT UPDATE STATES PATIENT REPORTS PAIN IS WORSENING. ( PI #3).

  Patient problems: Pain

  MAUDE report 23576064 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). 30-OCT-2023: PATIENT REPORTED PAIN WAS WORSENING. AE UPGRADED TO SAE AND PATIENT SCHEDULED FOR BONE GRAFT FIXATION OF THE CALCANEUS ON THE LEFT FOOT. (PI #2) 25-JAN-2024: UNDERWENT SURGICAL INTERVENTION FOR ARTHROTOMY OF ANKLE JOINT WITH DEBRIDEMENT OF ARTHRITIS TO REMOVE LOOSE BODY LATERAL GUTTER, LEFT; PARTIAL EXCISION DISTAL FIBULA FOR DECOMPRESSION; MEDIAL DISPLACEMENT CALCANEAL OSTEOTOMY (SEE ATTACHED OPERATIVE NOTES). (PI #2)

  Patient problems: Arthritis; Pain

  MAUDE report 23575939 ↗
• InjuryJan 23, 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 IMPLANT SUBSIDENCE.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 21215856 ↗
• InjurySep 10, 2024Break; Fracture; Break; Fracture

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT PRESENTED WITH PAIN AND MAY REQUIRE A REVISION SURGERY DUE TO BROKEN PEGS IN THE TALAR DOME.

  Patient problems: Implant Pain

  MAUDE report 20185090 ↗
• InjuryFeb 29, 2024Break; Fracture; Device Dislodged or Dislocated; Osseointegration Problem; Migration; Break; Fracture; 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 DUE TO POSSIBLE FRACTURE OF THE POSTERIOR TIBIA PEG AND/OR TALAR PEGS.

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

  MAUDE report 18813303 ↗
• InjuryFeb 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REMOVAL SURGERY OF THE CURRENT TALAR IMPLANT DUE TO EARLY COLLAPSE OF THE TIBIAL SIDE WITHOUT TRAUMA. THERE IS A FRACTURE PRESENT IN THE TIBIA. THE PHYSICIAN REPORTED THAT THE PATIENT WILL NEED INTRAMEDULLARY FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 18764013 ↗
• InjuryDec 28, 2023Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; 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 THE TIBIAL AND TALAR COMPONENTS. THE SURGERY WON'T BE DONE UNTIL AT LEAST FEBRUARY.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 18414207 ↗
• InjuryOct 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND DURING REVISION IT WAS NOTED THAT THE PEGS WERE BROKEN OFF OF THE ADAPTIS TALAR DOME AND THE DOME ITSELF WAS LOOSE FROM THE TALUS. DOME AND PEGS WERE EXPLANTED (DOME EASILY, PEGS WERE ALL FUSED) AND A NEW SIZE 1 FLAT CUT ADAPTIS TALAR DOME WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15563111 ↗
• InjurySep 2, 2021Migration; Migration

  IT WAS REPORTED THAT THE PROSTHESIS APPEARS TO HAVE SUBSIDED ANTERIORLY. PATIENT STATES THAT SHE HAS SORENESS AT THE MEDIAL AND LATERAL ASPECT OF HER RIGHT ANKLE. SHE NOTES THAT SHE HAS CUT BACK ON FORMAL PT, ATTENDING ONCE WEEKLY DUE TO SORENESS. SHE NOTES HER CONCERNS ABOUT OVERWORKING HER ANKLE. PATIENT NOTES THAT SHE ONLY BEGAN AGGRESSIVE EXERCISES THE LAST 2 TO 4 TIMES SHE HAS LAST BEEN AT PT. PRIOR TO SURGICAL TREATMENT PATIENT NOTES STIFFNESS AND LIMITED ROM OF HER ANKLE. HOWEVER, SHE NOTES IMPROVEMENT OF ANKLE ROM.

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

  MAUDE report 12418138 ↗