SIGMA 9505-01-218Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FEMORAL NOTCH IMPACTOR · Class 1
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma femoral notch impactor is a surgical tool used to seat knee implant parts. Its 184 reports include no deaths and 1 injury. Most describe the tool's tip or other parts breaking during knee surgery, with pieces removed and no harm reported. Reports in the last 12 months (3) are down from 9 in the prior 12 months, and 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
- 183
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10603295225256), received between Jul 7, 2017 and Apr 16, 2026 — classified as 1 injury, 182 malfunctions.
The most frequently reported specific device problem is “Break” (148 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, 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
- Break148
- Scratched Material9
- Material Deformation8
- Material Integrity Problem6
- Crack5
- Naturally Worn4
- Device-Device Incompatibility3
- Loose or Intermittent Connection3
Patient problems
- No Consequences Or Impact To Patient89
- No Clinical Signs, Symptoms or Conditions80
- No Information9
- Insufficient Information6
- No Code Available4
- Not Applicable2
Recent adverse event reports
The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE TIBIAL JIG STYLUS PLASTIC END BROKE OFF. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT. WHEN USING SECONDARY IMPACTOR SIGMA NOTCH IMPACTOR TIP BROKE. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897111 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT THE SIGMA IMPACTOR TIP BROKE WHILE IMPACTING FEMUR. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854090 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT THE SIGMA FEMORAL IMPACTOR BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED. NO DELAY OR ADVERSE EVENT WAS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393552 ↗MalfunctionOct 24, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). WHEN IMPACTING FEMUR SIGMA IMPACTOR TIP BROKE. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383381 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT WHEN IMPACTING FEMUR IMPLANT INITIALLY RED KNOB BROKE OFF. ALL PIECES WERE RECOVERED AND NO HARM WAS DONE TO THE PATIENT. THEN WITH THE SECONDARY IMPACTOR THE SIGMA IMPACTOR TIP BROKE. ALL PIECES WERE RECOVERED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368102 ↗MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: "VISUAL INSPECTION REVEALED ONE PORTION BROKEN AT THE LATERAL SIDE OF THE RADEL HEAD. DEVICE HAD SIGNS OF HEAVY USAGE ON ITS OVERALL SURFACE AND THE BROKEN PORTION WAS NOT RETURNED FOR EVALUATION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279967 ↗MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: "VISUAL INSPECTION REVEALED ONE PORTION BROKEN AT THE LATERAL SIDE OF THE RADEL HEAD. DEVICE HAD SIGNS OF HEAVY USAGE ON ITS OVERALL SURFACE AND THE BROKEN PORTION WAS NOT RETURNED FOR EVALUATION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279958 ↗MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: "VISUAL INSPECTION REVEALED ONE PORTION BROKEN AT THE LATERAL SIDE OF THE RADEL HEAD. DEVICE HAD SIGNS OF HEAVY USAGE ON ITS OVERALL SURFACE AND THE BROKEN PORTION WAS NOT RETURNED FOR EVALUATION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279754 ↗MalfunctionSep 3, 2025Break; Break
IT WAS REPORTED THAT SIGMA FEMORAL NOTCH IMPACTOR BROKE WHILE IMPACTING FEMUR IMPLANT IN. ALL PIECES WERE RECOVERED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952398 ↗MalfunctionNov 7, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20632594 ↗MalfunctionNov 7, 2024Break; Break
IT WAS REPORTED THAT THE PLASTIC BROKE IN HALF. SURGICAL DELAY WAS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20632194 ↗MalfunctionSep 6, 2024Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE ON IMPACTION OF COMPONENT.
Patient problems: Insufficient Information
MAUDE report 20155544 ↗MalfunctionJul 31, 2024Break; Break
IT WAS REPORTED IMPACTOR PLASTIC BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19874066 ↗MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility
THE FEMORAL IMPACTOR AND HANDLE HAVE FUSED TOGETHER AND COULD NOT BE PULLED APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643833 ↗MalfunctionMay 16, 2024Break; Break
IT WAS REPORTED THAT THE FEMORAL NOTCH IMPACTOR BROKE WHILE IMPLANTING FINAL FEMORAL COMPONENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19330453 ↗MalfunctionApr 30, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY. IT DID NOT CAUSE A DELAY, NO PARTS WERE LEFT IN THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19211998 ↗MalfunctionMar 11, 2024Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE WHILE IMPACTING FEM TRIAL. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18873510 ↗MalfunctionFeb 22, 2024Break; Break
IT WAS REPORTED THAT THE SIGMA NOTCH IMPACTOR BROKE INTO TWO PIECES DURING IMPACTION. SLIGHT DELAY IN CASE WHILE OPENING BACK UP INSTRUMENT TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18756882 ↗MalfunctionJan 16, 2024Break; Break
IT WAS REPORTED THAT SIGMA FEMORAL IMPACTOR BROKE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18520333 ↗MalfunctionDec 4, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT UNIVERSAL HANDLE PIN HAS BROKEN AND THE FEMORAL IMPACTOR IS STUCK IN PLACE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18263784 ↗MalfunctionNov 16, 2023Break; Break
WHILE IMPACTING THE FEMORAL IMPLANT, THE SIGMA HP FEMORAL NOTCH IMPACTOR BROKE INTO TWO PIECES ON THE BLACK RUBBER PART OF IMPACTOR. ALL PIECES WERE RETRIEVED FROM THE STERILE FIELD AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18153863 ↗MalfunctionOct 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS JAMMED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929918 ↗MalfunctionOct 5, 2023Break; Break
IT WAS REPORTED THAT DURING FEMUR IMPACTION THE SIGMA HP FEM NOTCH IMPACTOR BROKE. BLACK PLASTIC BROKE IN HALF OFF OF METAL PART OF INSTRUMENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17883101 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT SIGMA IMPACTOR BROKE AT BLACK PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17643160 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT THE SIGMA IMPACTOR BROKE AT BLACK PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17643128 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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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