GENESIS II 71441554Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT IMPACTOR HEAD SIZE 3-8 · Class 2
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Genesis II high flex insert impactor head is a surgical tool used to seat the plastic insert during knee replacement. Many of the 113 reports describe the tool breaking or its tip snapping off while impacting the insert, and some describe fractures of the tool. The reports include 17 injuries and no deaths, and one lists a third-degree burn. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 113
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 03596010497376), received between Feb 26, 2019 and Jul 5, 2026 — classified as 17 injuries, 96 malfunctions.
The most frequently reported specific device problem is “Break” (69 reports).
2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break69
- Fracture43
- Material Fragmentation2
- Crack1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions88
- No Consequences Or Impact To Patient12
- No Known Impact Or Consequence To Patient7
- No Patient Involvement4
- Full thickness (Third Degree) Burn1
- Injury1
- No Code Available1
Recent adverse event reports
The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE UPON HITTING. 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 25713136 ↗MalfunctionJun 2, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE WHEN IMPACTING THE FINAL INSERT. 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 25364364 ↗MalfunctionApr 30, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF THE GII PS HIGH FLEX IMPCTR HD 3-8 BROKE OFF WHILE IMPACTING THE HIGH-FLEX POLYETHYLENE COMPONENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046275 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII PS HIGH FLEX IMPCTR HD 3-8 BROKE DURING THE INSERTION OF THE POLY INSERT, EXTERNALLY TO THE PATIENT'S ANATOMY. IT WAS NEVER INSIDE OF THE PATIENT. ALL PARTS WERE FOUND. THE PROCEDURE WAS PERFORMED, 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 24725752 ↗MalfunctionFeb 16, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE WHILE TRYING TO IMPLANT INSERT. ALL PIECES WERE REMOVED AND ACCOUNT FOR. WHEN THE IMPACTOR PIECE BROKE, THE PIECE FELL ON DRAPING. THEY DID NOT NEED TO BE RETRIEVED FROM THE 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 24344403 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING, THE TIP OF THE GII PS HIGH FLEX IMPCTR HD 3-8 SNAPPED AT THE JUNCTION WITH THE HANDLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816563 ↗MalfunctionNov 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PS HIGH FLEX IMPCTR HD 3-8 BROKE WHEN IMPACTING POLY. NO PIECES FELL INSIDE PATIENT THE PROCEDURE WAS PERFORMED, 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 23677340 ↗MalfunctionOct 2, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE TIP OF A GII PS HIGH FLEX IMPCTR HD 3-8 BROKE OFF WHILE IMPACTING. AT THIS TIME, IT IS UNKNOWN IF ANY PIECES FELL 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 23200375 ↗MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901454 ↗MalfunctionJul 9, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF THE GII PS HIGH FLEX IMPCTR HD 3-8 BROKE IN HALF, WHILE IMPACTING THE POLY. THE BROKEN PIECE WAS REMOVED, BUT IT WAS NOT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 22465368 ↗MalfunctionMay 13, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE ON IMPACT. NO PARTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT 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 22010612 ↗MalfunctionMar 6, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, DURING IMPACTION, THE GII PS HIGH FLEX IMPCTR HD 3-8 BROKE. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543075 ↗MalfunctionJan 13, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA POLY EXCHANGE, THE HEAD OF ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 SHEARED OFF WHEN IMPACTING THE FINAL INSERT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139054 ↗MalfunctionJan 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF THE GII PS HIGH FLEX IMPCTR HD 3-8- CRACKED IN TWO PIECES, WHILE INSERTING POLY. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21063932 ↗MalfunctionDec 19, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE. 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 20977180 ↗MalfunctionNov 26, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII PS HIGH FLEX IMPCTR HD 3-8 BROKE IN HALF DURING IMPACTION. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20784207 ↗MalfunctionOct 28, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY, ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE, AND NO DELAY WAS REPORTED. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543920 ↗MalfunctionOct 24, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII PS HIGH FLEX IMPCTR HD 3-8 FRACTURED DURING USE. ONE PIECE FELL OFF OF IMPACTOR BUT NOT INTO THE PATIENT. ALL PIECES RECOVERED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT 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 20522989 ↗MalfunctionJul 12, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 FRACTURED UPON IMPACTION WITH THE HAMMER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731114 ↗MalfunctionJun 20, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, THE IMPACTOR TIP OF ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE WHILE IMPACTING THE POLY. THE PIECE WAS RETRIEVED BY HAND. 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 19576703 ↗MalfunctionJun 20, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA, THE IMPACTOR TIP OF ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE WHILE IMPACTING THE POLY. THE PIECE WAS RETRIEVED BY HAND. 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 19575839 ↗MalfunctionApr 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE GII PS HIGH FLEX IMPCTR HD 3-8 BROKE WHILE IMPACTING THE POLY. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BUT IT IS UNKNOWN HOW. PATIENT WAS NOT HARM DUE TO THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011903 ↗MalfunctionFeb 16, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) GII PS HIGH FLEX INSERT IMPACTOR HEAD SIZE 3-8 BROKE WHEN WAS IMPACTING. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721381 ↗MalfunctionJan 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII PS HIGH FLEX IMPCTR HD 3-8 BROKE OFF ON IMPACT. IT IS UNKNOWN IF PIECES FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18511324 ↗MalfunctionJan 12, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PS HIGH FLEX IMPCTR HD 3-8 BROKE ON IMPACT. NOTHING FELL INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 18503755 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.
- Z-0730-2019 · Jan 7, 2019 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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