GENESISRecalls & 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
- 76
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 14 models of GENESIS 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 Jan 19, 2018 and Jan 7, 2026 — classified as 19 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Break” (22 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 GENESIS problems
Device problems
- Break22
- Device Markings/Labelling Problem19
- Naturally Worn15
- Fracture10
- Defective Device3
- Detachment of Device or Device Component3
- Incomplete or Inadequate Connection3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Injury10
- No Known Impact Or Consequence To Patient4
- Failure of Implant2
- Foreign Body In Patient2
- No Consequences Or Impact To Patient2
- No Information2
- Discomfort1
GENESIS models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GENESIS 114943PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER50 reports
- GENESIS 725004PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- GENESIS 114861PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- GENESIS 71210001PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- GENESIS 114968PLATE, FIXATION, BONE2 reports
- GENESIS 71210002PIN, FIXATION, THREADED2 reports
- GENESIS 71210003PIN, FIXATION, THREADED2 reports
- GENESIS 71204524PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- GENESIS 726203PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 727304PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71248338PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71243308PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71243609PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GENESIS 71243619PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent GENESIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Fracture
IT WAS REPORTED THAT AFTER A UKR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE BLADE OF THE GENESIS UNI FEMORAL LARGE WAS BROKEN. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING REVISION SURGERY ON AN UNKNOWN DATE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23989656 ↗InjuryDec 19, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER A TKA WAS PERFORMED ON (B)(6) 2011, THE PATIENT PRESENTED PAIN AND DISCOMFORT DUE TO THE BREAKAGE OF THE GENESIS UNI FEMORAL LARGE. SURGERY TO REMOVE THE BROKEN PIECE WAS PERFORMED ON (B)(6) 2024, REVISION SURGERY NOT SCHEDULED YET.
Patient problems: Discomfort; Failure of Implant; Implant Pain
MAUDE report 20984762 ↗MalfunctionSep 2, 2024Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A GENESIS CALIPER WAS RUSTY AND ALSO THE NUT FELL OUT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A COMPETITOR DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20118395 ↗MalfunctionApr 11, 2024Fracture; Difficult or Delayed Separation; Fracture; Difficult or Delayed Separation
IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE INSERTING THE GNS TROCAR PIN 1/8 IN. X {} 5IN INTO THE TWIN PEG BLOCK, DID NOT MAKE IT FAR ENOUGH THROUGH THE TWIN PEG BLOCK TO MAKE A BONE HOLE BEFORE IT WAS COLD WELDED AND BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088723 ↗InjuryDec 8, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED WITH AN X-RAY THAT THE DRILL PIN TIP HAD BROKEN OFF DURING SURGERY AND WAS BURIED INSIDE OF THE PATIENT. THE BROKEN PIECE HAS NOT BEEN RETRIEVED FROM PATIENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 18291549 ↗MalfunctionNov 25, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE THUMBSCREW ON A GENESIS CALIPER BROKE OFF AND FELL ON FLOOR. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15864109 ↗InjuryJul 29, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS PIN AND DRILL SET BROKE WHEN THE SURGEON WAS DRILLING THE HOLES, PRIOR TO PINNING TO SECURE AND FINISH THE TIBIAL REAM. THE BROKEN PART COULD NOT BE REMOVED AND REMAINED IN THE PATIENT'S TIBIA. SURGERY WAS FINISHED WITHOUT FURTHER USAGE OF THE DRILL. NO SIGNIFICANT DELAYS REPORTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 15136635 ↗MalfunctionMar 16, 2022Break; Break
IT WAS REPORTED THAT THE GENESIS CALIPER WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM HAPPENED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13778301 ↗MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING SET-UP FOR A TKA SURGERY, THE SCREW OF A GENESIS CALIPER WAS MISSING BECAUSE IT NO LONGER STAYS IN THE GUIDE. AS THIS HAPPENED BEFORE THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13549326 ↗MalfunctionFeb 14, 2022Break; Break
IT WAS REPORTED THAT A GENESIS CALIPERS WAS OBSERVED TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13529671 ↗MalfunctionFeb 10, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT, DURING CLEANING, IT WAS NOTICED THAT THE GENESIS CALIPER WAS FOUND CHIPS AND CRACKS. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13506610 ↗InjuryFeb 7, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, A GENESIS CALIPER BROKE INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476544 ↗MalfunctionFeb 3, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, THE THUMB SCREW OF THE GENESIS CALIPER BROKE OFF. NO PIECES FELL INTO PATIENT. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446712 ↗MalfunctionJan 5, 2022Component Missing; Component Missing
IT WAS REPORTED THAT, AFTER A TKA, WAS RETURNED A GENESIS CALIPER AND WAS FOUND MISSING THE HOLDING SCREW. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172212 ↗MalfunctionNov 25, 2021Break; Break
IT WAS REPORTED THAT, DURING TKA SURGERY, THE THUMB SCREW OF A GENESIS CALIPER BROKE OFF. IT WAS CONFIRMED THAT NO PIECES FELL INTO THE PATIENT. 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 12874525 ↗
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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