INFINITY™ 33680023 (UDI 00889797101547)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889797101547), received between Feb 8, 2022 and Nov 12, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Migration” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 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). ON (B)(6) 2024: PATIENT REPORTED PERSISTENT PAIN AND SWELLING. NO FURTHER INFORMAT ON (B)(6) 2024: PATIENT REPORTED PAIN WAS WORSENING. AE UPGRADED TO SAE AND PATIENT HAD THE FOLLOWING PROCEDURES PERFORMED: TARSAL TUNNEL RELEASE; RIGHT TENOSYNOVECTOMY FLEXOR HALLUCIS LONGUS RIGHT; EXCISION MEDIAL TALUS AND CALCANEUS OSTEOPHYTE RIGHT; BONE GRAFT MEDIAL MALLEOLAR CYST AND DEBRIDEMENT, MEDIAL ANKLE JOINT. (SEE ATTACHED OPERATIVE NOTES). ON (B)(6) 2024: PATIENT IMPROVING POST-OP BUT STILL EXPERIENCING ONGOING PERSISTENT PAIN IN SUBTALAR JOINT. STEROID INJECTION ADMINISTERED. ON (B)(6) 2025: MOST RECENT UPDATE STATES PATIENT REPORTS NO CHANGE AND STILL HAVING PAIN IN ANKLE JOINT AREA. ANOTHER STEROID INJECTION WAS ADMINISTERED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23536460 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STRYKER ITAR-2 (INFINITY WITH ADAPTIS) STUDY. PERSISTENT PAIN. PT REPORTED HIS PAIN HAS BEEN GRADUALLY INCREASING OVER THE PAST 6 MONTHS. HE HAS PAIN WHEN AMBULATING. DENIES REST PAIN. DENIES FEVERS CURRENTLY. ENDORSES 6/10 PAIN, SHARP, DULL, CONSTANT WHEN WALKING.

  Patient problems: Pain

  MAUDE report 23535931 ↗
• 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 23402228 ↗
• InjurySep 10, 2025Loss of Osseointegration; Insufficient Device Problem Information; Migration; Loss of Osseointegration; Insufficient Device Problem Information; Migration

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

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 23019111 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. TALAR COMPONENT IMPINGEMENT AND CONTINUED PAIN SUBJECT CONTINUES TO HAVE SUSTAINED ANTERIOR MEDIA ANKLE AND DISTAL TIBIAL PAIN. PAIN IS LIKELY DUE TO IMPINGEMENT BETWEEN HIS MEDIAL MALLEOLUS AND TALAR COMPONENT, LIKELY RELATED TO HIS MILD VARUS ALIGNMENT.

  Patient problems: Implant Pain; Joint Impingement

  MAUDE report 22963645 ↗
• InjuryJul 11, 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 A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 22479853 ↗
• InjuryMay 15, 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 BOTH THE TIBIAL AND TALAR COMPONENTS DUE TO ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22029791 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(4) INFINITY¿ WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) (B)(6) 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE. THIS EVENT IS CAPTURED UNDER STRYKER REFERENCE #'S (B)(4). UPDATE 01 SEP 2022: NO CHANGE. SUTURES REMAIN, DRY DRESSING APPLIED. WALKING BOOT CONTINUED. WEIGHT-BEAR FOR TOLERATED IN THE WALKING BOOT. UPDATE 05 OCT 2022: WORSENING. PATIENTS ENTIRE ANKLE JOINT IS INFECTED SUBSEQUENT FROM SEEDING POSTEROLATERAL. PATIENT NOTED SWELLING AND CHILLS. WILL DO CULTURES IMPLANT REMOVAL IRRIGATION DEBRIDEMENT, ANTIBIOTIC SPACER, AND ADMISSION WITH IV ANTIBIOTICS. UPDATE 11 OCT 2022: SURGICAL INTERVENTION DUE TO DEEP INFECTION. REOPERATION WITH REMOVAL OF TIBIAL AND/OR TALAR IMPLANTED COMPONENTS. THIS EVENT IS CAPTURED THIS RECORD."

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 21572307 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(4) INFINITY WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: ON (B)(6) 2022, A PATIENT WAS PRESENTED WITH LATERAL ANKLE LACERATION FROM A BUSH HOGGING ACCIDENT ON (B)(6) 2022. THEY ORIGINALLY HAD 8 STITCHES BUT CUT THEM AT HOME A WEEK AFTER THAN BEING PLACED WHICH HAS LED TO WOUND DEHISCENCE. IT IS FAIRLY DEEP WITH SEROSANGUINEOUS DRAINAGE. KEFLEX X7 DAYS. DISCUSSED SIGNS AND SYMPTOMS OF INFECTION TO MONITOR FOR AND DRY DRESSING CHANGES EITHER DAILY OR TWICE A DAY DEPENDING ON DRAINAGE TO THE LATERAL LACERATION. UPDATE 24 AUG 2022: WORSENING. PLAN FOR RIGHT ANKLE IRRIGATION AND DEBRIDEMENT, BONE BIOPSY, PARTIAL EXCISION OF FIBULA, WITH POSSIBLE ADJACENT TISSUE TRANSFER. UPDATE 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE."

  Patient problems: Osteomyelitis; Wound Dehiscence

  MAUDE report 21572187 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(4) INFINITY WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6)2022: ON (B)(6)) 2022, A PATIENT WAS PRESENTED WITH LATERAL ANKLE LACERATION FROM A BUSH HOGGING ACCIDENT ON (B)(6) 2022. THEY ORIGINALLY HAD 8 STITCHES BUT CUT THEM AT HOME A WEEK AFTER THAN BEING PLACED WHICH HAS LED TO WOUND DEHISCENCE. IT IS FAIRLY DEEP WITH SEROSANGUINEOUS DRAINAGE. KEFLEX X7 DAYS. DISCUSSED SIGNS AND SYMPTOMS OF INFECTION TO MONITOR FOR AND DRY DRESSING CHANGES EITHER DAILY OR TWICE A DAY DEPENDING ON DRAINAGE TO THE LATERAL LACERATION. UPDATE 24 AUG 2022: WORSENING. PLAN FOR RIGHT ANKLE IRRIGATION AND DEBRIDEMENT, BONE BIOPSY, PARTIAL EXCISION OF FIBULA, WITH POSSIBLE ADJACENT TISSUE TRANSFER. UPDATE 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE."

  Patient problems: Osteomyelitis; Wound Dehiscence

  MAUDE report 21572062 ↗
• 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). 03 MAR 2022: WOUND DRAINAGE. DELAYED WOUND HEALING. NOTED A VERY SMALL AREA OF DRAINAGE ON THE INCISION ANTERIOR TO ANKLE 02 MAR 22. TOPICAL ANTIBIOTIC WAS PRESCRIBED. ON 16 MAR 2022 SMALL ESCHAR 1CM FROM WOUND WAS NOTED. DRAINAGE WAS NOTED IN JUN 2022 PATIENT RECEIVED 3 WEEK COURSE OF KEFLEX AND THE GRANULOMA WAS INSPECTED. 27 JUL 2022 NO FURTHER ISSUES. DRAINAGE RESOLVED."

  Patient problems: Wound Dehiscence

  MAUDE report 20426088 ↗
• InjuryOct 9, 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). ON (B)(6) 2022: DROPFOOT. PATIENT SEEN ON (B)(6) 2022, FOR FOLLOW UP AND TO CONSIDER LEFT LOWER EXTREMITY NERVE CONDUCTION STUDY/EMG ORDERED TO EVALUATE DROP FOOT IF NOT IMPROVED BY NEXT VISIT. PATIENT STATED HE NOTICED THIS EVER SINCE COMING OUT OF CAST AND STARTING ANKLE RANGE OF MOTION EXERCISES AT HOME WHEN HE CANNOT ACTIVELY BRING HIS FOOT UP. ON (B)(6) 2022: IMPROVING. PATIENT IS SHOWING SOME ELEMENT OF FIRING DORSIFLEXORS, NO EMG NERVE CONDUCTION STUDY AT THIS TIME. MAY EVENTUALLY REQUIRE EMG NERVE CONDUCTION STUDY."

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 20407966 ↗
• InjuryDec 21, 2023Adverse 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 PROCEDURE DUE TO INFECTION. THE PATIENT WAS IMPLANTED WITH A CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 18378116 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED 6 WEEKS POST LEFT TOTAL ANKLE REPLACEMENT PROCEDURE. IT WAS NOTED THAT THERE WAS ANTERIOR SURGICAL WOUND DEHISCENCE AND SEROUS FLUID DRAINAGE. THE PHYSICIAN COMPLETED AND IRRIGATION AND DEBRIDEMENT ON OCTOBER 4, 2023. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 18034784 ↗
• InjurySep 11, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD AN INFINITY TOTAL ANKLE SYSTEM IMPLANTED ON (B)(6) 2021. IT WAS NOTED THAT "THE TOP FELL OFF HIS LEG AND THE BOTTOM FELL OFF HIS ANKLE." IT WAS REPORTED AS DISLODGED. THE PATIENT WAITED 6 MONTHS AND THEN UNDERWENT A REVISION PROCEDURE.

  Patient problems: Implant Pain; Joint Dislocation; Joint Laxity; Limb Fracture

  MAUDE report 17725777 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PATIENT PRESENTED WITH NERVE PAIN AT THE RIGHT ANKLE. THE TREATMENT INVOLVED THE EFFECTED LEG BEING PLACED IN SHORT LEG CAST, ICE, ELEVATE. OVERALL, PATIENT IS HEALING AND DOING WELL POST-OPERATIVELY. TREATMENT INCLUDED MEDICATION AND INCREASED ACTIVITY. HEALING AND PROGRESSING WELL POSTOPERATIVELY. NERVE PAIN SHOULD CONTINUE TO IMPROVE. TREATMENT INCLUDED MEDICATION AND VISCOSE PAD FOR SHOE.

  Patient problems: Implant Pain; Nerve Damage

  MAUDE report 17242724 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE IS A NON-HEALING WOUND OVER ANTERIOR ANKLE WHICH PROBES DOWN TO BONE. THE PATIENT PRESENTED FROM WOUND CARE WHO EXPRESSED CONCERN OVER A WORSENING WOUND ON HIS ANTERIOR ANKLE. THE PATIENT UNFORTUNATELY HAS A NON-HEALING WOUND OVER THEIR ANTERIOR ANKLE WHICH PROBES DOWN TO BONE. GIVEN THE LARGE WOUND AND LIKELY EXPOSED PROSTHESIS, THE NEEDS TO RETURN TO OR FOR I&D AND POLY EXCHANGE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 16765843 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER PATIENT UNDERWENT A DEBRIDEMENT AND IRRIGATION WITH A POLY SWAP, THE PATIENTS CONDITION IMPROVED. HOWEVER, A COUPLE OF WEEKS LATER THE PATIENT WORSENED AND HAD INCOMPLETE HEALING OF THE TENDON EXPOSURE. IRRIGATION DEBRIDEMENT OF THE SUPERFICIAL SKIN. IF IT APPEARED TO BE DEEPLY INFECTED AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS AND INSERT AN ANTIBIOTIC IMPLANT ALONG WITH A WOUND VAC AND SYNOVECTOMY OF EXTENSOR TENDON.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 13501980 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSTOPERATIVE WOUND DEHISCENCE IN A SMALL AREA WITH NO DRAINAGE. THE PATIENT WAS ADVISED TO WASH THE AREA WITH SOAP AND WATER AND MAINTAIN A DRY DRESSING APPLIED TO WOUND DEHISCENCE. EIGHT DAYS LATER IT WAS FOUND THAT THE AREA WAS WORSENING AND INSPECTION FOUND MODERATE ERYTHEMA WITH PURULENT DRAINAGE. THERE WAS ALSO MODERATE SWELLING. PALPATION TENDERNESS AROUND THE INCISIONAL AREA. PATIENT IS DIGRESSING WITH WORSENING PAIN REDNESS AND DRAINAGE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR LEFT ANKLE REVISION WITH IRRIGATION DEBRIDEMENT AND A POLYETHYLENE EXCHANGE.

  Patient problems: Erythema; Implant Pain; Post Operative Wound Infection; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 13501844 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AND INFINITY SYSTEM IMPLANTED. THE ANKLE AREA BECAME INFECTED. THE PHYSICIAN PERFORMED A WASH OUT AND POLY SWAP. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13485405 ↗