ECHELONRecalls & reported problems across all models
Smith & Nephew, Inc. · 30 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
- 50
- Recalls
- 0
We found 30 models of ECHELON 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 May 8, 2015 and Oct 2, 2023 — classified as 50 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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 ECHELON problems
Device problems
- Fracture19
- Break16
- Adverse Event Without Identified Device or Use Problem6
- Loose or Intermittent Connection3
- Insufficient Device Problem Information2
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Biocompatibility1
Patient problems
- Injury27
- Failure of Implant13
- Pain7
- Bone Fracture(s)6
- Ambulation or Postural Difficulties3
- No Clinical Signs, Symptoms or Conditions3
- Fall2
- Hip Fracture2
ECHELON models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ECHELON 71341011Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- ECHELON 71340113Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- ECHELON 71340111Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- ECHELON 71340413Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- ECHELON 71340112Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- ECHELON 71344415Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- ECHELON 71344412Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- ECHELON 71340512Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ECHELON 71340612Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ECHELON 71340812Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ECHELON 71341024Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ECHELON 71345512Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- ECHELON 71346613Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- ECHELON 71345516Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- ECHELON 71310112Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71310214PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ECHELON 71310312Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71340115Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71340211Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71340212Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71340416Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71340516Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71364014Prosthesis, hip, femoral component, cemented, metal1 report
- ECHELON 71340412Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71367221Prosthesis, hip, femoral component, cemented, metal1 report
- ECHELON 71315112Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71927978Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ECHELON 71927979PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ECHELON 71927980PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ECHELON 71342013PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent ECHELON adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE REMOVING THE TRIAL, THE MAGNET FELL OUT OF A ECHELON PRIMARY HIGH OFFSET TRIAL NECK SIZE 12. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAYS, USING THE SAME REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17852345 ↗InjuryMay 5, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A RIGHT THA REVISION SURGERY HAD BEEN PERFORMED TO IMPLANT AN ECH POR STD 260MM BOW SZ 16 R STEM, IT FRACTURED ON AN UNSPECIFIED DATE. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2023 TO ADDRESS THIS EVENT. THE STEM WAS EXCHANGED FOR A ZIMMER WAGNER CONE (305MM LENGTH) SOLUTION. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 16877876 ↗InjuryFeb 5, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED, THE ECH POR 190MM STR SZ 13 THAT WAS IMPLANTED, BROKE. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. NO MEDICAL INTERVENTION HAS BEEN REPORTED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 16302053 ↗InjuryJan 31, 2023Fracture; Fracture
IT WAS REPORTED, FOUR YEARS AFTER A THR SURGERY HAD BEEN PERFORMED ON 2014, THE PATIENT EXPERIENCED SUDDEN ONSET OF THIGH PAIN AND INABILITY TO WALK. THE PATIENT WENT TO THE HOSPITAL WITH PAIN ON (B)(6) 2022. AS A RESULT OF THE EVALUATION OF THE PATIENT, X-RAYS WERE TAKEN ON (B)(6) 2022 AND SHOWED THAT THE ECHELON 190MM POROUS FEMORAL COMPONENT SIZE 13 WAS FRACTURED. THIS WAS ADDRESSED VIA REVISION SURGERY TO EXPLANT THE STEM, THE DATE OF THE REVISION IS NOT KNOWN. CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant; Pain
MAUDE report 16273473 ↗InjurySep 26, 2022Biocompatibility; Migration; Biocompatibility; Migration
IT WAS REPORTED THAT AFTER A RIGHT MOM-THR HAD BEEN PERFORMED, PATIENT EXPERIENCED COBALT LEVELS AT 270 (H) AND CHROMIUM LEVELS AT 31.0 (H). THERE WAS AN INCREASED SUBSIDENCE OF THE FEMORAL STEM WHEN COMPARED WITH PREVIOUS, WHICH RAISED SUSPICION FOR COMPONENT LOOSENING. THERE WERE DEGENERATIVE CHANGES IN LOWER LUMBER SPINE AND AT THE SACROILIAC JOINTS. SCLEROSIS ABOUT SYMPHYSIS PUBIS LIKELY REFLECTING LONG-STANDING STRESS-RELATED CHANGES, AS WELL AS DEGENERATIVE CHANGES IN THE LOWER LUMBER SPINE AND AT THE SACROILIAC JOINTS. SCLEROSIS ABOUT SYMPHYSIS PUBIS LIKELY REFLECTING LONG-STANDING STRESS-RELATED CHANGES. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Metal Related Pathology
MAUDE report 15483676 ↗InjuryFeb 9, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT, AFTER A PRIMARY LEFT TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT FELL DOWN AND EXPERIENCED A VANCOUVER TYPE B3 PERIPROSTHETIC FRACTURE. THEREFORE, A REVISION SURGERY WAS PERFORMED IN ORDER TO SOLVE THIS ADVERSE EVENT, AND IT WAS FOUND THAT THE ACETABULAR COMPONENT WAS STABLE, BUT THE FEMORAL COMPONENT WAS REVISED WITH AN ECHELON 260MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR SIZE 12 LEFT. ON SIXTH WEEK CONTROL, IT WAS FOUND ON X-RAYS THAT THE ECHELON 260MM POROUS BOWED FEMORAL STEM IS BENDING. IT IS UNKNOWN IF ANY INTERVENTION HAS BEEN PERFORMED. IT IS UNKNOWN IF A SECOND REVISION SURGERY HAS BEEN SCHEDULED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 13499022 ↗InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A JOINT CAPSULE INFECTION AND THE ECHELON HA STD 260 BOW S 12 L WAS BROKEN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE REF NO HOLE SHELL SZ 52MM, ECHELON HA STD 260 BOW S 12 L, OXINIUM FEM HD 12/14 32MM +8 AND AN UNKNOWN REFLECTION LINER WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Bacterial Infection; Failure of Implant
MAUDE report 12847152 ↗MalfunctionOct 15, 2021Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9MM, 1 GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 11MM, 1 GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 9MM, 1 GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 11MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 9MM AND 1 GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 3-4 11MM ARE CRACKED AND WORN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12643363 ↗InjurySep 28, 2021Break; Break
IT WAS REPORTED THAT, AFTER A THR PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT FELL AND EXPERIENCED PAIN, ON (B)(6) 2021. X-RAYS DETERMINED THE BREAK OF ECHELON POR 190MM STR SIZE 11 AND PATIENT IS SCHEDULED FOR A REVISION SURGERY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. REVISION SURGERY DATE TO BE PERFORMED, IS UNKNOWN
Patient problems: Failure of Implant; Implant Pain
MAUDE report 12541632 ↗InjuryAug 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT CAME FOR A FOLLOW UP VISIT ON (B)(6) 2021 WITH MARKED DISABILITY TO WALK, X RAY SHOWS CHANGE IN POSITION OF THE ECHELON 190MM POROUS FEMORAL COMPONENT SIZE 15 AND MRI ( MAVRIC) SHOWED IMPLANT LOOSENING. THERE WAS AN EDEMA IN THE FEMUR, DISTAL TO THE FEMORAL STEM. ALSO, THERE WAS THINNING OF THE FEMORAL CORTICES. PET CT WITH TRIPLE PHASE BONE SCAN WAS DONE AND CONFIRMED LOOSENING IN THE PRIMARY PATHOLOGY AND WAS NO INFECTION. REVISION SURGERY WAS PRESCRIBED TO REPLACE THE DEVICE BUT THE PATIENT HAS NOT AGREED TO IT YET. CURRENT HEALTH STATE OF THE PATIENT IS AMBULATORY WITH WALKER AND MOVING WITHIN THE HOUSE.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Inadequate Osseointegration; Swelling/ Edema
MAUDE report 12317012 ↗InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
*US LEGAL* IT WAS REPORTED THAT AFTER THE REVISION SURGERY OF THE THA RIGHT HIP CONSTRUCT HAD BEEN PERFORMED ON (B)(6) 2013 (COVERED UNDER (B)(4)), THE PLAINTIFF EXPERIMENTED INTERMITTENT, DULL, SHARP PAIN IN THE RIGHT HIP. THE PLAINTIFF ALSO EXPERIMENTED NUMBNESS AND WEAKNESS ON AMBULATION. THE PLAINTIFF WAS TREATED WITH MEDICATIONS AND STARTED FEELING BETTER 9 WEEKS AFTER THE SURGERY. THE PLAINTIFF OUTCOME IS UNKNOWN.
Patient problems: Ambulation or Postural Difficulties; Numbness; Pain
MAUDE report 11940889 ↗InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER PRIMARY THR, PATIENT PRESENTED A FRACTURE AND A REVISION SURGERY WAS PERFORMED TO EXPLANT THE ECHELON CEMENTED FEMORAL COMPONENT SZ 14,225MM. DEVICE WAS REPLACED WITH AN IMPLANT FROM A COMPETITOR. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Bone Fracture(s)
MAUDE report 11376941 ↗MalfunctionJan 27, 2021Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN THE OUTER PACKAGE OF THE ECH CEM FEM SZ 12 175MM WAS OPENED A LONG BLACK HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE NEXT LEVEL OF STERILE PACKAGE WAS THEN OPENED ONTO THE STERILE FIELD. THIS WAS INSPECTED AND WAS FOUND ACCEPTABLE TO USE, PROCEDURE WAS COMPLETED USING THE SAME DEVICE. HAIR WAS IN OUTER STERILE PACKAGE, NOT WITHIN STERILE INNER PACKAGE. SO IT NEVER CONTACTED IMPLANT. THIS HAPPENED DURING THR PROCEDURE, THERE WAS A DELAY OF LESS THAN 30 MIN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11235593 ↗InjuryNov 3, 2020Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, AFTER THE PATIENT HAD BEEN IMPLANTED AN ECHELON STEM ON (B)(6) 2014 DURING A REVISION SURGERY, THE PATIENT EXPERIENCED A DISLOCATION BECAUSE THE STEM FRACTURED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020: ONLY THE FEMORAL HEAD, STEM AND ACCORD WIRES WERE EXPLANTED. THE PATIENT HAS HAD COMPLICATIONS SINCE THIS PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Bone Fracture(s); Failure of Implant; Hip Fracture; Joint Dislocation; Joint Laxity; Metal Related Pathology; Pain; Thromboembolism
MAUDE report 10781732 ↗InjuryOct 30, 2020Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN ECHELEON FEMORAL STEM DUE TO COMPLICATIONS WITH IT. THE PRIMARY SURGERY WENT SUCCESSFULLY BUT IMMEDIATELY AFTER THE COMPLETION OF SUCH SURGERY IMAGING REVEALED THAT THERE WAS A PERFORATION OF THE FEMORAL STEM THROUGH THE PROXIMAL FEMORAL SHAFT. THE EVENT WAS RESOLVED VIA REVISION SURGERY IN WHICH THE STEM AND THE HEAD WERE REMOVED.
Patient problems: Failure of Implant
MAUDE report 10766577 ↗
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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