RENOVATIONRecalls & reported problems across all models
Smith & Nephew, Inc. · 16 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 16 models of RENOVATION by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2018 and Mar 20, 2026 — classified as 19 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (35 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 RENOVATION problems
Device problems
- Break35
- Fracture17
- Failure to Align3
- Defective Component1
- Deformation Due to Compressive Stress1
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Known Impact Or Consequence To Patient12
- No Consequences Or Impact To Patient4
- Injury3
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- No Patient Involvement1
RENOVATION models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RENOVATION 71369007PLATE, FIXATION, BONE11 reports
- RENOVATION 71369045APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT9 reports
- RENOVATION 71369300ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- RENOVATION 71367566ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- RENOVATION 71367541Prosthesis, hip, femoral component, cemented, metal4 reports
- RENOVATION 71367553Prosthesis, hip, femoral component, cemented, metal4 reports
- RENOVATION 71369200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- RENOVATION 71367561ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- RENOVATION 71369517ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- RENOVATION 71369006APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- RENOVATION 71367548PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RENOVATION 71369420Prosthesis, hip, femoral component, cemented, metal1 report
- RENOVATION 71367552Prosthesis, hip, femoral component, cemented, metal1 report
- RENOVATION 71369308CHISEL, SURGICAL, MANUAL1 report
- RENOVATION 71369519ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- RENOVATION 75100519CHISEL, SURGICAL, MANUAL1 report
Recent RENOVATION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Fracture
IT WAS REPORTED THAT, DURING SURGERY, THE RONGEUR 300MM W/ TEETH BROKE. ALL PIECES WERE RETRIEVED. 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 24647420 ↗MalfunctionMar 14, 2026Fracture; Material Twisted/Bent
IT WAS REPORTED THAT, DURING A THR, THE TIP OF ONE (1) RONGEUR 200MM W/TEETH BROKE. THE PIECE THAT CLAMPS DOWN WAS BENT 15-20° TO ONE SIDE. NO PIECES BROKE OFF INTO THE PATIENT. 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 24600347 ↗InjuryJan 13, 2026Fracture
IT WAS REPORTED THAT, DURING A ATQ REVIEW SURGERY, THE SURGEON REQUESTED THE DRILL BIT TO DEEPEN THE FEMORAL CANAL, AND DURING THE DRILLING ONE (1) CEMENT DRILL 6MM BROKE INSIDE THE PATIENT'S FEMUR. THE SURGEON TRIED FOR A LONG TIME TO REMOVE THE REMAINING PIECE OF THE DRILL BIT BUT WAS UNSUCCESSFUL, AND DECIDED TO PROCEED, LEAVING THE BROKEN TIP OF THE DRILL BIT IN THE FEMORAL CANAL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24052182 ↗MalfunctionNov 17, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR PROCEDURE, THE TIP OF THE CARBIDE PUNCH BROKE OFF WHILE BEING USED OUTSIDE THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A SIMILAR S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566668 ↗MalfunctionApr 28, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A REVISION THR SURGERY, ONE (1) CEMENT DRILL 4.5MM FRACTURED WHILE DRILLING THROUGH THE CEMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 21918491 ↗MalfunctionOct 4, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR REVISION SURGERY, WHEN REMOVING CEMENT FROM THE FEMORAL CANAL, THE CEMENT DRILL 4.5MM BREAK FROM IMPACT ON THE CEMENT. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY WAS REPORTED OR INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371172 ↗MalfunctionNov 8, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A HIP REVISION SURGERY (NON S+N IMPLANT), A V SPLITTER BROKE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO PIECES FELL INSIDE THE PATIENT, NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18096536 ↗MalfunctionNov 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE BOX OF THE BLADE DID NOT HAVE THE CASING, AND THE PLASTIC PART OF A THIN OSTEO BLD ROUND END 20MM THAT MAKES IT STERILE, WAS FOUND TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACKUP DEVICE. THE PATIENT WAS NOT INVOLVED AT THE TIME OF THE FINDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18070388 ↗MalfunctionNov 1, 2023Break; Break
IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) CEMENT DRILL 4.5MM WAS FOUND BROKEN. 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 18050181 ↗MalfunctionAug 4, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY CONDUCTED TO REMOVE A COMPETITOR'S KNEE PROTHESIS, THE TIP OF A CEMENT DRILL 4.5MM FRACTURED WHILE USING THE DRILL ON THE TIBIA. THE SURGEON REMOVED THE DRILL TIP. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAY. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17456500 ↗MalfunctionApr 18, 2023Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress
IT WAS REPORTED THAT, DURING THR SURGERY, A CHISEL 8MM X 17 WAS FOUND DULL AND CHIPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16764482 ↗MalfunctionMar 6, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING USE, THE INSTRUMENTS BENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED. UPON INVESTIGATION, IT WAS FOUND THAT THE CARBIDE PUNCH HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16492916 ↗MalfunctionFeb 15, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) CARBIDE PUNCH FRACTURED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16383584 ↗InjuryAug 29, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR 2 STAGE REVISION (1 STAGE) PROCEDURE, WHILE SURGEON WAS IN THE PROCESS OF REMOVING CEMENT FROM THE FEMORAL CANAL WITH THE CEMENT DRILL 4.5MM FROM THE RENOVATION SET, THE DRILL TIP SNAPPED OFF. THIS CAUSED THE DEVICE BECAME LODGED IN THE FEMORAL CANAL. AN ATTEMPT WAS MADE TO RETRIEVE THE DRILL BIT INITIALLY, THE FLUOROSCOPY SHOWED THE DRILL TIP WEDGED BETWEEN A REVISION KNEE STEM AND THE FEMORAL CORTEX. SURGEON COMMENTED THAT THIS ADVERSE EVENT WOULD BE ADDRESSED DURING THE REVISION OF THE KNEE PROSTHESIS BY REMOVING THE BROKEN DRILL TIP. SURGERY WAS RESUMED, WITH MORE THAN AN ONE HOUR DELAY. IT IS UNKNOWN HOW SURGERY WAS FINISHED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 15316108 ↗MalfunctionAug 29, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A THR PROCEDURE, THE TOP THE REVERSE CURETTE 7MM HANDLE BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15313174 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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