Cadence Total Ankle SystemRecalls & reported problems across all models
Smith & Nephew, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 18 models of Cadence Total Ankle System by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2023 and May 1, 2026 — classified as 15 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Fracture” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cadence Total Ankle System problems
Device problems
- Fracture29
- Adverse Event Without Identified Device or Use Problem12
- Break9
- Biocompatibility1
- Crack1
- Detachment of Device or Device Component1
- Failure to Osseointegrate1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Medical device site infection3
- Periprosthetic fracture3
- Insufficient Information2
- Joint Impingement2
- Pain2
- Adhesion(s)1
- Arthralgia1
Cadence Total Ankle System models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cadence Total Ankle System 10203102Orthopedic manual surgical instrument10 reports
- Cadence Total Ankle System 10204305Orthopedic manual surgical instrument8 reports
- Cadence Total Ankle System 10203098Orthopedic manual surgical instrument5 reports
- Cadence Total Ankle System 10204306Orthopedic manual surgical instrument5 reports
- Cadence Total Ankle System 10203101Orthopedic manual surgical instrument4 reports
- Cadence Total Ankle System 10204191Orthopedic manual surgical instrument3 reports
- Cadence Total Ankle System 10207112PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Cadence Total Ankle System 10208103PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Cadence Total Ankle System 10203001Orthopedic manual surgical instrument2 reports
- Cadence Total Ankle System 10208101PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Cadence Total Ankle System 10203007Orthopedic manual surgical instrument1 report
- Cadence Total Ankle System 10206106Orthopedic manual surgical instrument1 report
- Cadence Total Ankle System 10207101PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10207102PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10207113PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10207211PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10209337PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10209406PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent Cadence Total Ankle System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 1, 2026Biocompatibility
IT WAS REPORTED THAT, AFTER A TOTAL ANKLE REPLACEMENT (TAR), PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A RIGHT ANKLE INFECTION WITH ONSET ON (B)(6) 2020. THE ADVERSE EVENT WAS ADDRESSED SURGICALLY WITH AN INCISION AND DRAINAGE (I&D) PROCEDURE, DURING WHICH A POLYETHYLENE LINER AND AN ANTIBIOTIC SPACER WERE PLACED FOR INFECTION MANAGEMENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 25062093 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TAR SURGERY HAD BEEN PERFORMED WITH CADENCE SYSTEM ON (B)(6) 2017, THE CLINICAL SUBJECT HAD A REVISION FUSION REVISION FLAP AND REMOVAL OF EXTERNAL FIXATOR AND SPACER ON (B)(6) 2021. THE ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 25052018 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TAR SURGERY HAD BEEN PERFORMED WITH CADENCE SYSTEM ON (B)(6) 2017, THE CLINICAL SUBJECT EXPERIENCES LATERAL RIGHT ANKLE PAIN FOR APPROXIMATELY A YEAR. THE SUBJECT REPORTED WORSENING PAIN, DESCRIBED AS SHARP AND SEVERE, RATED 8/10, AND EXACERBATED BY WEIGHT BEARING AND AMBULATION AT THE CLINICAL FOLLOW ON (B)(6) 2023. THIS ADVERSE EVENT WAS EVALUATED FOR FURTHER DIAGNOSTIC WITH A CT SCAN TO ASSESS POSSIBLE LATERAL GUTTER IMPINGEMENT AND PRESCRIBED A MEDIAL HEEL WEDGE AS INTERIM MANAGEMENT. THE CURRENT OUTCOME OF THE SUBJECT IS ONGOING.
Patient problems: Pain
MAUDE report 25038279 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TAR SURGERY HAD BEEN PERFORMED WITH CADENCE SYSTEM ON (B)(6) 2017, THE CLINICAL SUBJECT EXPERIENCES A TIBIA FRACTURE FOLLOWING MULTIPLE POSTOPERATIVE FALLS, PATIENT WAS EVALUATED IN CLINIC ON (B)(6) 2017, AND A CT SCAN REVEALED A MINIMALLY DISPLACED POSTERIOR TIBIA FRACTURE. CLINICAL MANAGEMENT CONSISTED OF EXTENDED IMMOBILIZATION, WITH CASTING CONTINUED FOR AN ADDITIONAL THREE WEEKS BEYOND THE ORIGINAL POSTOPERATIVE PLAN. NO SURGICAL REVISION WAS REQUIRED AND FOLLOW-UP IMAGING DEMONSTRATED FRACTURE HEALING. THE ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017.
Patient problems: Bone Fracture(s); Fall; Periprosthetic fracture
MAUDE report 25038162 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT TOTAL ANKLE REPLACEMENT (TAR) PERFORMED ON (B)(6) 2017, ON (B)(6) 2017 THE PATIENT WAS NOTED TO HAVE MACERATION OVER THE ANTERIOR SURGICAL WOUND BED, WHICH SUBSEQUENTLY DEVELOPED INTO A SUPERFICIAL CELLULITIS AROUND THE ANTERIOR INCISION. THIS ADVERSE EVENT WAS TREATED WITH A COURSE OF ORAL ANTIBIOTICS. FOLLOW-UP ASSESSMENTS DEMONSTRATED PROGRESSIVE IMPROVEMENT, AND THE INFECTION RESOLVED WITH COMPLETE WOUND HEALING.
Patient problems: Cellulitis
MAUDE report 25032093 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN ANKLE SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2018, THE CLINICAL SUBJECT EXPERIENCED A PERIPROSTHETIC MEDIAL MALLEOLUS FRACTURE ON (B)(6) 2018 WHILE COMPLETING PHYSICAL THERAPY. THIS ADVERSE EVENT WAS SOLVED BY A ORIF SURGERY ON (B)(6) 2018. THE CURRENT OUTCOME OF THE SUBJECT IS RECOVERED/RESOLVED
Patient problems: Periprosthetic fracture
MAUDE report 25024681 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN ANKLE SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2018, THE CLINICAL SUBJECT EXPERIENCED A PERIPROSTHETIC FRACTURE AROUND INTERNAL PROSTHETIC RIGHT ANKLE ON (B)(6) 2018. THIS ADVERSE EVENT WAS SOLVED BY A SURGERY ON (B)(6) 2018 AND MEDICATION. THE CURRENT OUTCOME OF THE SUBJECT IS RECOVERED/RESOLVED.
Patient problems: Periprosthetic fracture
MAUDE report 25024674 ↗MalfunctionFeb 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TAR, A SPRING ON THE DISTAL TIBIAL ALIGNMENT BLOCK FELL OUT INTO PATIENT'S ANKLE. THE PIECE WAS RECOVERED PICK-UPS AND LAID ON THE TABLE. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24410386 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT, DURING A TAA, ONE (1) CADENCE TIBIAL IMPACTOR TIP CRACKED AND BROKE AFTER INSERTION WHILE SETTING IMPLANT IN PATIENT. GREEN PLASTIC DEBRIS WAS REMOVED FROM PATIENT INTRA OPERATIVELY. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377329 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT, DURING AN ANKLE SURGERY, THE SURGEON SEATED THE TIBIAL IMPLANT AND USED ONE (1) CADENCE IMPLANT PROTECTOR - RIGHT WHEN SEATING THE TALAR IMPLANT WITH THE TALAR IMPACTOR. FORCE WAS DRIVEN THROUGH THE TALAR IMPACTOR TO CRACK THE CADENCE IMPLANT PROTECTOR - RIGHT IN TWO PIECES. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244994 ↗MalfunctionJan 27, 2026Crack; Fracture
IT WAS REPORTED THAT, DURING AN ANKLE SURGERY, THE SURGEON SEATED THE TIBIAL IMPLANT USING ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP; FORCE WAS DRIVEN THROUGH THE INSTRUMENT TO CAUSE CRACKING AND FRACTURE OF BLACK PLASTIC PIECE OF THE CADENCE 45 DEGREE TIBIAL IMPACTOR TIP. THE PROCEDURE WAS ALREADY COMPLETED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188837 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT, DURING A TOTAL ANKLE SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - RIGHT WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849843 ↗MalfunctionNov 20, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TAR, SURGEON WAS USING THE CADENCE 45 DEGREE TIBIAL IMPACTOR TIP TO IMPACT A 3X LEFT TIBIAL IMPLANT. HOWEVER, THE BLACK TIP OF IMPACTOR BROKE WHILE DOING IMPLANT SEATING. THE BROKEN PIECE OF BLACK PLASTIC WAS RETRIEVED FROM THE BROKEN TIBIAL IMPACTOR TIP INSTRUMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605082 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT, DURING A TOTAL ANKLE SURGERY, ONE (1) CADENCE IMPLANT PROTECTOR - LEFT BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459673 ↗MalfunctionOct 27, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TOTAL ANKLE ARTHROPLASTY SURGERY DURING IMPACTION OF THE DEFINITIVE TIBIAL IMPLANT, SURGEON NOTICED THAT A PIECE OF ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP BROKE OFF AS HE REMOVED THE IMPACTOR FROM INSIDE THE PATIENT. THERE WAS ONE PIECE, HE IDENTIFIED IT IMMEDIATELY IN THE PATIENT, AND HE REMOVED IT WITHOUT FURTHER ISSUE WITH A KOCHER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23397489 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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