EMPERIONRecalls & reported problems across all models
Smith & Nephew, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls
- 0
We found 14 models of EMPERION by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and Dec 19, 2025 — classified as 37 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (21 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 EMPERION problems
Device problems
- Fracture21
- Break20
- Insufficient Device Problem Information8
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Deformation1
- Mechanical Problem1
Patient problems
- Injury16
- No Clinical Signs, Symptoms or Conditions11
- Failure of Implant10
- Pain8
- Bone Fracture(s)5
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient2
- Osteolysis2
EMPERION models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EMPERION 71291302Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate10 reports
- EMPERION 71360920Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- EMPERION 71360919Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- EMPERION 71290902Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- EMPERION 71291301Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- EMPERION 71291102Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- EMPERION 71291669Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- EMPERION 71364036Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- EMPERION 71291101Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- EMPERION 71291502Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- EMPERION 71291665Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- EMPERION 71360917Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- EMPERION 71290923Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- EMPERION 71291501Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
Recent EMPERION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE TRIAL REMOVAL HANDLE BROKE WHILE EXTRACTING TRIAL STEM FROM PATIENT'S FEMUR. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849909 ↗MalfunctionMay 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, THE TIP OF ONE (1) TRIAL REMOVAL HOOK BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22117388 ↗MalfunctionOct 22, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, A REDAPT CASE, WHERE A TRIAL REMOVAL HANDLE BROKE DURING REGULAR USE-EXTRACTION OF FEMORAL STEM TRIAL. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR'S DEVICE., A HOOK HANDLE. PATIENT WAS ANESTHETIZED DURING THE DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502443 ↗InjuryAug 27, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER UNDERGOING A TOTAL HIP REPLACEMENT (THR) IN 2014 DUE TO UNKNOWN REASONS PATIENT SUFFERED BREAKAGE OF AN EMPERION STEM. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH THE EMP STEM 9 SO 140MM, HEAD AND LINER WERE EXCHANGED. DURING PROCEDURE, THEY ENCOUNTERED SIGNIFICANT SCLEROSIS ON THE DISTAL ASPECT OF THE SLEEVE, SO A DECISION WAS MADE TO START PREPARING A TROCHANTERIC OSTEOTOMY. HOWEVER, THERE HAD ALREADY BEEN A SMALL CRACK IN THE LATERAL ASPECT OF THE GREATER TROCHANTER. PATIENT WAS ON TOE TOUCH WEIGHTBEARING. SHE HAD STRICT ABDUCTOR PRECAUTIONS FOR SIX TO TWELVE WEEKS WHICH DEPENDED ON THE FOUR WEEK POSTOPERATIVE X-RAY. IN ADDITION, SEVEN WEEKS POST-OP PATIENT SHOWED ALIGNMENT AND APPEARANCE OF THE HARDWARE UNCHANGED AND WITHOUT ACUTE OSSEOUS COMPLICATION.
Patient problems: Failure of Implant; Radiolucent Lines
MAUDE report 20076040 ↗InjuryNov 5, 2022Fracture; Fracture
IT WAS REPORTED THAT AFTER A THR REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 , IT WAS IDENTIFIED THAT THE EMP 11 STEM PRIMARY HO WAS FRACTURED AT THE STEM/NECK JUNCTION ON (B)(6) 2022 . THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 15740872 ↗InjuryApr 26, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A RIGHT THR ON (B)(6) 2015 DUE TO RIGHT HIP OSTEOARTHRITIS WITH LIMITED RANGE OF MOTION, THE PATIENT EXPERIENCED PAIN, GROIN TENDERNESS, LIMITED INTERNAL AND EXTERNAL ROTATION. CT SCAN SHOWED PROSTHETIC FRACTURE OF STEM AND X-RAYS CONFIRMED BROKEN STEM DISPLACED, FRACTURED, AND ANGULATED AT THE LEVEL OF THE GREATER TROCHANTER/INTERTROCHANTERIC REGION. THE PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP ON (B)(6) 2021. IT IS UNKNOWN THE STATUS OF THE PATIENT.
Patient problems: Deformity/ Disfigurement; Failure of Implant; Implant Pain; Loss of Range of Motion; Pain
MAUDE report 14212753 ↗MalfunctionApr 25, 2022Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING THE SURGERY THE EMP SLV REMOVAL TOOL WAS BEING PROPERLY USED BUT WHEN IMPACTED, THE SURFACE BECAME DISASSOCIATED FROM THE HANDLE (OUTSIDE THE PATIENT). THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192632 ↗MalfunctionJan 26, 2022Solder Joint Fracture; Solder Joint Fracture
IT WAS REPORTED THAT THE WELD BROKE ON THE EMP SLAV REMOVAL TOOL HANDLE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13353741 ↗InjuryNov 12, 2021Break; Break
IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO THE FRACTURE OF AN EMP 13 STEM PRIMARY SO IMPLANTED 10 YEARS AGO AND REVISED TO A LONG STEM ECHELON. DURING THE SURGERY, THE EMP 13 STEM PRIMARY SO, THE EMP13 SLV SM CONE 1 SPOUT AND THE BIOLOX DELTA HEAD 36 MM 12/14 M / +4 WERE EXPLANTED. EXTENSIVE OSTEOTOMIES WERE PERFORMED DUE TO THE SIGNIFICANT INGROWTH OF BONE ONTO PROXIMAL SLEEVE. MOREOVER, THE SHELL AND THE CERAMIC LINER WERE LEFT UNTOUCHED. THE EXPLANTED DEVICES ARE NOT ABLE TO BE EVALUATED. NO FURTHER INFORMATION AVAILABLE REGARDING THE POST OPERATIVE CONDITION OF PATIENT IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 12804686 ↗InjuryOct 13, 2021Break; Break
IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON 2009, THE PATIENT EXPERIENCED SEVERE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO SOLVE THIS ADVERSE EVENT. THE EMP 13 STEM PRIMARY HO WAS FOUND BROKEN JUST PROXIMAL TO THE SLEEVE. AN ETO WAS REQUIRED TO REMOVE THE STEM AND AN ACROSS STEM WAS IMPLANTED. IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.
Patient problems: Failure of Implant; Pain
MAUDE report 12624042 ↗InjuryAug 5, 2021Fracture; Fracture
IT WAS REPORTED THAT AN EMPERION TRIAL REMOVAL HANDLE BROKE DURING SURGERY, WHILE INSTRUMENT WAS INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12285330 ↗MalfunctionJul 12, 2021Break; Break
IT WAS REPORTED THAT, DURING THR SURGERY, A TRIAL REMOVAL HANDLE BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12155295 ↗InjuryJun 18, 2021Break; Break
IT WAS REPORTED THAT, DURING A THR, AN EMPERION SLEEVE/ STEM SEPARATOR BROKE DURING IMPACTION, INSIDE THE PATIENT. IT IS UNKNOWN IF THE SURGERY WAS RESUMED WITH A BACK UP DEVICE, NO DELAY WAS REPORTED. PATIENT WAS NOT IMPACTED BY THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12028643 ↗MalfunctionApr 6, 2021Break; Break
IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE EMPERION SLV REMOVAL TOOL WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11617545 ↗InjuryFeb 28, 2021Break; Break
IT WAS REPORTED THAT, A PATIENT HAD AN EMERSION 13 STEM PRIMARY HO IMPLANTED ON (B)(6) 2009. HOWEVER, THE PATIENT PRESENTED TO HOSPITAL WITH PAIN IN HIP, AND IT WAS FOUND THAT THE EMERSION STEM HAD SNAPPED IN HALF AT THE JUNCTION OF THE SLEEVE. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE OLD STEM WAS REMOVED THROUGH ETO AND OSTEOTOME BLADES, AND A REDAPT STEM WAS INSERTED. NO OPERATIVE REPORTS AVAILABLE. 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; Osteolysis; Pain
MAUDE report 11390906 ↗
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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