SIGMA 9505-01-235Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE DISTAL FEMORAL RESECTION GUIDE · Class 1
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma high performance distal femoral resection guide is a surgical instrument used to set the cut on the femur during knee replacement. The 27 reports describe guides that jam, stick or won't slide freely during adjustment, pieces that don't fit together, and tips or spikes that broke off; several mention the parts locking together and not coming apart. No deaths or injuries were reported. No recalls name this device, and reports have dropped from the prior 12 months.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295225409), received between Dec 3, 2017 and Oct 24, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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
- Device-Device Incompatibility9
- Mechanical Jam8
- Appropriate Device Problem Term/Code Not Available4
- Material Twisted/Bent3
- Break2
- Device Issue2
- Difficult to Insert1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient13
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIECES WERE NOT FITTING TOGETHER. THE EVENT DID NOT OCCUR IN A PROCEDURE. THERE WAS NO SURGEON INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378419 ↗MalfunctionJun 21, 2024Device-Device Incompatibility; Mechanical Jam; Illegible Information; Device-Device Incompatibility; Mechanical Jam; Illegible Information
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19589440 ↗MalfunctionNov 13, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE TIP OF THE UNIVERSAL HANDLE THAT ENGAGES CUT BLOCKS BROKE OFF, AND ONE OF THE SPIKES FOR THE TIBIAL PREP TRAY BROKE. BOTH INSTRUMENTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124164 ↗MalfunctionNov 17, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT 2 PIECES OF THE DISTAL FEMORAL CUTTING JIG HAVE BECOME STUCK AND WONT DISENGAGE EACH OTHER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15812559 ↗MalfunctionApr 20, 2022Device-Device Incompatibility; Device-Device Incompatibility
INSTRUMENTS ARE JAMMED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14160416 ↗MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility
RESECTION DIAL GUIDE WOULD NOT SLIDE FREELY ON RESECTION ALIGNMENT GUIDE OUTRIGGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13196757 ↗MalfunctionAug 10, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE RESECTION GUIDE DID NOT MOVE FREELY DURING ADJUSTMENT. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300320 ↗MalfunctionMay 13, 2021Device-Device Incompatibility; Device-Device Incompatibility
THE INSTRUMENTS ARE NORMALLY EASILY DISCONNECTED FROM EACH OTHER. THE FEMUR RESECTION GUIDE IS USED TO ADJUST FOR THE DISTAL FEMORAL CUT. ON TWO OF THE INSTRUMENTS, THIS SETTING DOES NOT WORK ANY LONGER. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11821815 ↗MalfunctionMay 13, 2021Device-Device Incompatibility; Device-Device Incompatibility
THE INSTRUMENTS ARE NORMALLY EASILY DISCONNECTED FROM EACH OTHER. THE FEMUR RESECTION GUIDE IS USED TO ADJUST FOR THE DISTAL FEMORAL CUT. ON TWO OF THE INSTRUMENTS, THIS SETTING DOES NOT WORK ANY LONGER. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11821787 ↗MalfunctionMay 10, 2021Device-Device Incompatibility; Device-Device Incompatibility
WHEN ATTACHING TO RESECTION GUIDE ON TO THE TWO POSTS OF THE ALIGNMENT GUIDE THE GUIDE IS UNABLE TO SLIDE UP AND DOWN ON THE TWO POSTS. IT BECOMES STUCK AT THE BASE OF THE TWO POSTS AND HAD TO BE PRIED APART WITH A COBB. NO NOTICEABLE BURRS OR BENT POSTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11797066 ↗MalfunctionMar 12, 2021Device-Device Incompatibility; Device-Device Incompatibility
NEW INSTRUMENTS, BUT THE RESECTION GUIDE DOES NOT FIR LIKE IT SHOULD INTO THE ALIGNMENT GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11476103 ↗MalfunctionJan 29, 2021Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam
A COMPARATIVE ANALYSIS OF THE PHOTO SHOWS THAT THE INSTRUMENT WAS TRANSFERRED IN WORKING CONDITION, THE FIXING TAB IS SHIFTED TO THE RIGHT, THE BUTTON IS RELEASED. ON THE RETURNED HANDLE, THE TONGUE IS NOT SHIFTED TO THE RIGHT, THE BUTTON IS PRESSED. INTERFERENCES IN THE ADJUSTING SCREW ARE VISIBLE. THE CAUSE OF THE BREAKDOWN IS THE USE IN A MEDICAL FACILITY. THE PRODUCT HAS BEEN DESTROYED, THERE WILL BE NO RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11254686 ↗MalfunctionJan 29, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
THE TOOL WAS NOT PERFORMING ITS FUNCTIONAL TASKS. THE PRODUCT BROKE BEFORE USE DUE TO WEAR OF THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11254619 ↗MalfunctionDec 10, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE KNOB ON THE DISTAL FEMORAL CUTTING GUIDE GETS STUCK AND THE SLEEVE WRENCH WON¿T PROPERLY GRASP THE TIBIAL SLEEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10986513 ↗MalfunctionNov 2, 2020Mechanical Jam; Mechanical Jam
ADDITIONAL INFORMATION RECEIVED STATING THAT THE AGENT DETECTED THE ISSUE DURING THE FIRST STEP OF THE SURGERY, AND THEN IT WAS OPENED THE MICROPORT (TIME NECESSARY TO OPEN THE DEVICE). AFTER THIS IT WAS COMPLETED THE SECOND SURGERY. IN TOTAL THERE WAS NO DELAY ON THE ENTIRE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10771693 ↗MalfunctionNov 2, 2020Mechanical Jam; Mechanical Jam
ADDITIONAL INFORMATION RECEIVED STATING THAT THE AGENT DETECTED THE ISSUE DURING THE FIRST STEP OF THE SURGERY, AND THEN IT WAS OPENED THE MICROPORT (TIME NECESSARY TO OPEN THE DEVICE). AFTER THIS IT WAS COMPLETED THE SECOND SURGERY. IN TOTAL THERE WAS NO DELAY ON THE ENTIRE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10771691 ↗MalfunctionSep 18, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE RESECTION DEPTH ADJUSTMENT DRUM FOR IM FEMUR GUIDE WAS LOCKING UP. UNABLE TO TURN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10554239 ↗MalfunctionFeb 25, 2020Material Twisted/Bent; Material Twisted/Bent
CUSTOMER IS COMPLAINING INSTRUMENT WITHOUT GIVING DETAILS. NO ADVERSE PATIENT IMPACT, NO PART REMAINING IN PATIENT, NO SURGERY DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9751304 ↗MalfunctionAug 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE DISTAL FEMORAL CUTTING JIG WOULD NOT ASSEMBLE PROPERLY. TWO PIECES GOT JAMMED TOGETHER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7801492 ↗MalfunctionAug 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE DIAL ON THE DISTAL CUTTER JIG IS SPINNING AND NOT LOCKING ON THE GUIDE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7784270 ↗MalfunctionJul 27, 2018Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE SURGEON COULD NOT ADJUST AMOUNT OF BONE CUTTING BECAUSE THE ADJUSTABLE KNOB WAS STIFF DURING TKA SURGERY ON (B)(6) 2018. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7726598 ↗MalfunctionMay 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED SIGMAL DISTAL FEM CONNECTOR IS LOCKED INSIDE DISTAL FEM RESECTION GUIDE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7553569 ↗MalfunctionMay 25, 2018Device Issue; Device Issue
IT WAS REPORTED THAT DURING THE REVISION OF THIS PATIENT'S RIGHT TOTAL BIOMET KNEE, THE DISTAL CUTTING GUIDE STUCK AND WOULD NOT ADJUST TO CONTROL DISTAL RESECTION. ALL PIECES WERE PRESENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7544192 ↗MalfunctionApr 9, 2018Difficult to Insert; Difficult to Insert
TOTAL KNEE REVISION ST VINCENTS PRIVATE HOSPITAL (B)(6) 2018. DISTAL FEMORAL RESECTION GUIDE AND CONNECTOR: UNABLE TO DIAL THE RESECTION GUIDE ALL THE WAY WHEN CONNECTOR IS INSERTED. SEEMS TO JAM UP. WRENCH: DOES NOT GRIP ON TIBIAL IMPLANT WHEN IN USE. FEMALE PATIENT INITIALS: (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7409017 ↗MalfunctionJan 16, 2018Device Issue; Device Issue
IT WAS REPORTED THAT WHEN ASSEMBLING THE DISTAL FEMORAL CUTTING GUIDE THE DIAL WOULD NOT SLIDE FREELY ON THE ARMS. IT COULD NOT BE REMOVED. A NEW TRAY WAS OPENED TO COMPLETE THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7193375 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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.
How reports and recalls are matched · Editorial policy · Report an error on this page