SYNERGYRecalls & reported problems across all models
Smith & Nephew, Inc. · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 142
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls
- 0
We found 52 models of SYNERGY by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 142 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2015 and Feb 21, 2026 — classified as 72 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Break” (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 SYNERGY problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Break21
- Connection Problem21
- Corroded20
- Insufficient Device Problem Information18
- Fracture17
- Defective Device11
- Incomplete or Inadequate Connection11
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- No Consequences Or Impact To Patient17
- Injury16
- Pain16
- No Patient Involvement12
- Failure of Implant11
- Unspecified Infection9
- Hip Fracture7
SYNERGY models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNERGY 71366408Prosthesis, hip, femoral component, cemented, metal16 reports
- SYNERGY 71366414Prosthesis, hip, femoral component, cemented, metal9 reports
- SYNERGY 71366514Prosthesis, hip, femoral component, cemented, metal8 reports
- SYNERGY 71366709Prosthesis, hip, femoral component, cemented, metal8 reports
- SYNERGY 71309113Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate6 reports
- SYNERGY 71366716Prosthesis, hip, femoral component, cemented, metal5 reports
- SYNERGY 71306612Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented4 reports
- SYNERGY 71306616Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented4 reports
- SYNERGY 71306617Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented4 reports
- SYNERGY 71366508Prosthesis, hip, femoral component, cemented, metal4 reports
- SYNERGY 71309012Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate4 reports
- SYNERGY 71306613Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- SYNERGY 71306614Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- SYNERGY 71306113PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- SYNERGY 71366712Prosthesis, hip, femoral component, cemented, metal3 reports
- SYNERGY 71366713Prosthesis, hip, femoral component, cemented, metal3 reports
- SYNERGY 71366714Prosthesis, hip, femoral component, cemented, metal3 reports
- SYNERGY 71309114Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- SYNERGY 71306611Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- SYNERGY 71306615Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- SYNERGY 71306111PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SYNERGY 71306112PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SYNERGY 71306115PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SYNERGY 71306116PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SYNERGY 71306117PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SYNERGY 71316211Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- SYNERGY 71366708Prosthesis, hip, femoral component, cemented, metal2 reports
- SYNERGY 71366710Prosthesis, hip, femoral component, cemented, metal2 reports
- SYNERGY 71366715Prosthesis, hip, femoral component, cemented, metal2 reports
- SYNERGY 71366717Prosthesis, hip, femoral component, cemented, metal2 reports
- SYNERGY 71366718Prosthesis, hip, femoral component, cemented, metal2 reports
- SYNERGY 71309011Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- SYNERGY 71309013Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- SYNERGY 71930715PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SYNERGY 71306610Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- SYNERGY 71306715Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- SYNERGY 71306814PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SYNERGY 71366209Prosthesis, hip, femoral component, cemented, metal1 report
- SYNERGY 71306114PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SYNERGY 71306118PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SYNERGY 71316009Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- SYNERGY 71316010Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- SYNERGY 71316011Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- SYNERGY 71316013Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- SYNERGY 71316014Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- SYNERGY 71366711Prosthesis, hip, femoral component, cemented, metal1 report
- SYNERGY 71309009Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- SYNERGY 71309015Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- SYNERGY 71309016Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- SYNERGY 71309109Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- SYNERGY 71309115Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- SYNERGY 71309117Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
Recent SYNERGY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2026Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, WHERE THE BROACH ATTACHES TO THE BROACH HANDLE IT BROKE OFF AND THE STAFF WAS UNABLE TO GET THE BROACH TRIAL OUT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH AN EQUIVALENT S+N BACK-UP PRODUCT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24410360 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT DURING A HEMI THR SURGERY, ONE (1) SYN TRIAL NECK SZ 8-13 BROKE. THE PROCEDURE RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906217 ↗MalfunctionJul 30, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING A THR, A HOLE AND TEARS WERE NOTICED IN THE INNER CONTAINER OF ONE SYN CEM FEM COMP SZ 10, RENDERING THE DEVICE UNSTERILE. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22669079 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
T WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION OF ONE (1) SYN POR PLUS HA HO STEM SZ 17. THIS ADVERSE EVENT WAS RESOLVED THROUGH REVISION SURGERY ON (B)(6) 2025. THE PATIENT¿S CURRENT STATE IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22303418 ↗MalfunctionJun 1, 2025Degraded; Material Deformation; Degraded; Material Deformation
IT WAS REPORTED THAT, DURING A THR SURGERY, THE IMPLANT SITS ABOVE DESIRED DEPTH DUE TO WOKEN SYN TPRD RMR (SZ 8-9-10-11-12-17-18, TWO (2) SZ 13-14) AND AN UNKNOWN SYNERGY HIP INSTRUMENT. THE SURGERY WAS COMPLETED, AFTER A SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22121103 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THA REVISION SURGERY PERFORMED IN (B)(6) 2022, THE REVISION SURGERY FAILED DUE TO UNSPECIFIED REASONS. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IT REMAIN UNKNOWN WHICH COMPONENTS WERE REVISED DURING THIS PROCEDURE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21898675 ↗InjuryOct 4, 2024Fracture; Fracture
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A BROKEN STEM AT THE NECK. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE SYN POR PLUS HA SO STEM SZ 9 WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20376543 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER UNDERGOING A THR ON AN UNKNOWN DATE, PATIENT EXPERIENCED CALCAR FRACTURE WHICH RESULTED STEM TO SUBSIDE FROM ITS POSITION. SURGEON DID NOT FAULT S&N DEVICES AS IT WAS DUE TO A FRACTURE. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, THE SYN POR HO FEM COM SZ 14 AND OXINIUM FEM HD 12/14 36 MM +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS IN GOOD HEALTH.
Patient problems: Bone Fracture(s)
MAUDE report 19817493 ↗InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2024, A SYN POR PLUS HA HO STEM SZ 15 AND A 40MM OXINIUM MODULAR HEAD WERE REMOVED ON (B)(6) 2024 DUE TO A FEMORAL BONE FRACTURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 19593539 ↗InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT THA ON (B)(6) 2022, PATIENT SUSTAINED A MECHANICAL LOOSENING OF INTERNAL RIGHT HIP PROSTHETIC JOINT DUE TO A PERIPROSTHETIC FRACTURE THAT REQUIRED REVISION SURGERY ON (B)(6) 2022 AND IN WHICH THE STEM FEM SYNERGY SZ15, INSERT ACETABULAR OR3O XLPE OD 42 MM ID28 MM 2 MOBILITY AND HEAD OXINIUM FEM 12/14 TPR 28MM +0 WERE EXPLANTED AND EXCHANGED FOR SMITH & NEPHEW BACK-UP DEVICES. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Hip Fracture; Inadequate Osseointegration
MAUDE report 19554565 ↗InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THA ON (B)(6) 2020, PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE AROUND INTERNAL PROSTHETIC LEFT HIP JOINT THAT REQUIRED REVISION SURGERY ON (B)(6) 2020 IN WHICH THE STEM FEM SYNERGY SZ 16, INSERT ACETABULAR OR3O XLPE OD 46 MM ID28 MM 2 MOBILITY AND HEAD FEM TAPER 28MM + 0 WERE EXPLANTED AND EXCHANGED FOR SMITH & NEPHEW BACK-UP DEVICES. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Hip Fracture
MAUDE report 19554189 ↗InjuryFeb 15, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A MOM-THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2004, THE NECK OF THE SYNERGY POROUS FEMORAL COMPONENT SZ 16 FRACTURED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 16379307 ↗InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
STUDY NAME: LEFT THR WOUND INFECTION, STUDY ID: OR3O.2019.08, SUBJECT ID: 26-011, AE#: 1IT WAS REPORTED THAT DURING A CLINICAL STUDY, AFTER A THR PERFORMANCE ON FEB 18-2022, THE PATIENT EXPERIENCED A LEFT THR WOUND INFECTION. THE PATIENT UNDERGO A PERCUTANEOUS FINE NEEDLE ASPIRATION BIOPSY. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS RESOLVED AND IT WAS HOSPITALIZED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Post Operative Wound Infection
MAUDE report 15875794 ↗InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS WAS ADDRESSED ON (B)(6) 2019, TO EXCHANGE THE SYN POR HO FEM COM SZ 13, 40MM OXINIUM MODULAR HEAD, R3 20 DEG XLPE LNR 40MM ID X 60 OD AND TITANIUM MODULAR HEAD SLV 12/14 TPR +8 . IT IS UNKNOWN PATIENT'S CURRENT HEALTH STATUS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Insufficient Information
MAUDE report 15875790 ↗InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT THR SURGERY IN THE RIGHT HIP ON (B)(6) 2019, AND EXPERIENCED A RIGHT INTRAOPERATIVE CALCAR FRACTURE. THIS ADVERSE EVENT WAS RESOLVED BY UTILIZING CABLES; HOWEVER, IT REMAINS UNCLEAR WHAT CAUSED THE FRACTURE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Hip Fracture
MAUDE report 15535478 ↗
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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