CHSRecalls & 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
- 76
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 30 models of CHS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 76 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2018 and Aug 29, 2024 — classified as 13 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Break” (33 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 CHS problems
Device problems
- Break33
- Fracture13
- Material Deformation7
- Difficult to Insert4
- Connection Problem3
- Loose or Intermittent Connection3
- Mechanical Jam3
- Naturally Worn3
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Consequences Or Impact To Patient9
- Injury6
- No Known Impact Or Consequence To Patient6
- Pain2
- Bone Fracture(s)1
- Fall1
- Foreign Body In Patient1
CHS models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CHS 115035PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER16 reports
- CHS 110023REAMER8 reports
- CHS 71110060PLATE, FIXATION, BONE8 reports
- CHS 110054APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- CHS 110075Guide, surgical, instrument3 reports
- CHS 71110026PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- CHS 71134052PLATE, FIXATION, BONE3 reports
- CHS 110020TAMP2 reports
- CHS 124126APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- CHS 413501PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- CHS 71134060ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- CHS 3571129244PLATE, FIXATION, BONE2 reports
- CHS 3571129242PLATE, FIXATION, BONE2 reports
- CHS 110022WRENCH1 report
- CHS 110903ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- CHS 110960PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- CHS 121105ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- CHS 121107ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- CHS 121110ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- CHS 121142APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 124125APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 124130APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 71110024APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 71115045PLATE, FIXATION, BONE1 report
- CHS 71115062APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 71123134APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 71134032ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- CHS 71134054Prosthesis, hip, femoral component, cemented, metal1 report
- CHS 71970533APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- CHS 71110038Prosthesis, hip, femoral component, cemented, metal1 report
Recent CHS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROPHYLACTIC INTERNAL FIXATION OF THE RIGHT HIP IN (B)(6) 2019 DUE TO A BONE ISSUE WHICH WAS A RIGHT PROXIMAL NON OSSIFYING FIBROMA OF THE FEMUR. AFTER THE PROCEDURE, THE PATIENT HAD A RIGHT PROXIMAL FEMORAL SHAFT PERIPROSTHETIC FRACTURE. THIS ISSUE WAS ADDRESSED ON (B)(6) 2022 WITH AN OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT FEMORAL SHAFT FRACTURE UTILIZING AN INTRAMEDULLARY NAIL. AFTER PLACEMENT OF THE NAIL, IT WAS NOTED THAT THERE WAS A SMALL FRACTURE THAT PROPAGATED FROM THE PRIMARY FRACTURE ALONG THE POSTERIOR RIDGE OF THE PRIOR HARDWARE. THE FRACTURE EXTENDED PROXIMALLY TO THE LAG SCREWS BUT DID NOT EXTEND PROXIMAL TO THE SCREWS. THE REDUCTION AND THE CONSTRUCT REMAIN STABLE. THE PATIENT HAD A SATISFACTORY RESULT.
Patient problems: Bone Fracture(s); Fall
MAUDE report 20103008 ↗MalfunctionApr 29, 2024Break; Break
IT WAS REPORTED THAT, DURING A CHS PROCEDURE, THE LOCKING MECHANISM FOR THE DEPTH STOP OF ONE (1) POWER COMBINATION REAMER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19202556 ↗MalfunctionDec 19, 2023Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, WHEN INSERTING THE LAG SCREW WITH THE CLASSIC INSERTION WRENCH DEVICE, THE TIP OF THE DEVICE SNAPPED LOOSE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO PIECES WERE LEFT INSIDE OF THE PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18357505 ↗MalfunctionOct 10, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TIP AND PART OF THE HANDLE OF A POWER COMBINATION REAMER BROKE OFF. SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17905572 ↗MalfunctionOct 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (X1) AMBI INSERTION WRENCH WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861988 ↗MalfunctionSep 5, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY, THE TIP OF ONE (X1) HEX SCREWDRIVER BROKE OFF DURING USE INSIDE THE WOUND WHILE ADJUSTING THE FEMORAL SIZER. THE PIECE WAS LOCATED AND REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A SMITH AND NEPHEW BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17683412 ↗MalfunctionAug 24, 2023Fracture; Fracture
IT WAS REPORTED THAT, ONE (1) SELF HOLDING HEX SCREWDRIVER END WAS SHEARED OFF, AFTER THE SCREW WAS INSERTED INTO THE PLATE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17614293 ↗MalfunctionJul 20, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TRAUMA FIXATION SURGERY A CANN BARREL GUIDE-2 PIECE GOT BROKEN DURING NORMAL USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17361704 ↗MalfunctionApr 18, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, THE CONNECTION TO THE DRILL OF A POWER COMBINATION REAMER SNAPPED OFF DUE TO WEAR AND TEAR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16764578 ↗MalfunctionFeb 4, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF A HEX SCREWDRIVER BROKE OFF WHILE USING TO ADJUST THE AP SIZER. THE BROKEN TIP STAYED IN SIZER AND DID NOT FALL IN PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16301814 ↗MalfunctionJan 18, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING THE IMPLANTATION OF A HIP PROSTHESIS, THE SIDE SUPERIOR EXTREMITY OF A SL-PLUS/SLR-PLUS IMPACTOR BROKE. FURTHERMORE, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16195518 ↗MalfunctionAug 10, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE LOCKING MECHANISM ON THE POSITIVE STOP OF AN INT COMBINATION REAMER WAS WORN DOWN. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED. UPON INVESTIGATION, IT WAS FOUND THAT THE DEVICE IS FRACTURED INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15198143 ↗MalfunctionJun 9, 2022Break; Break
IT WAS REPORTED THAT, A INT LAG RETAINING ROD WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14640671 ↗MalfunctionJun 7, 2022Break; Break
IT WAS REPORTED THAT THE END OF RETAINING ROD OF THE CLASSIC INSERTION WRENCH WAS BROKEN OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14611785 ↗MalfunctionMay 20, 2022Break; Break
IT WAS REPORTED THAT, A DEPTH GAUGE {} SMALL WAS BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14450917 ↗
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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