SIGMA LCS 9505-02-024Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT KEEL PUNCH IMPACT · Class 1
All models of SIGMA LCS (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy SIGMA High Performance LCS keel punch impactor is a surgical instrument used to prepare the bone during knee replacement. The 54 reports mostly describe the tool breaking, coming apart, or no longer gripping and connecting properly to its handle, with parts detaching or wearing out during use. None of the reports describe a death or an injury. There are no recalls naming this device, and no reports were filed in the past 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295227441), received between Aug 10, 2017 and Mar 25, 2024 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Device-Device Incompatibility11
- Connection Problem9
- Naturally Worn7
- Detachment Of Device Component4
- Loose or Intermittent Connection4
- Defective Component3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient32
- No Clinical Signs, Symptoms or Conditions11
- No Information7
- No Code Available3
- Not Applicable3
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE KEEL MBT HANDLE WILL NOT RETAIN THE KEEL PUNCH .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18969947 ↗MalfunctionSep 19, 2022Break; Break
IT WAS REPORTED THAT THE MBT PUNCH IMPACTOR BOTTOM BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15447723 ↗MalfunctionJun 2, 2022Break; Break
IT WAS REPORTED THAT THE BUTTON ON MBT HANDLE BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572307 ↗MalfunctionMay 9, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TKA SURGERY. BEFORE SURGERY, ON (B)(6) 2022, AN OIL LIKE STICKY SUBSTANCE WAS FOUND ON THE IMPACTOR IN QUESTION WHEN ALL THE DEVICES FOR THE SURGERY WERE PREPARING. THE IMPACTOR WAS CLEANSED AT THE HOSPITAL AND USED IN THE SURGERY ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2022, A REQUEST WAS MADE TO INVESTIGATE THE CAUSE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14336798 ↗MalfunctionMar 3, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE KEEL PUNCHES ARE SLIPPING OFF THE HANDLE. IT NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13659154 ↗MalfunctionDec 29, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
MBT HANDLE NO LONGER CONNECTS TO KEEL PUNCH OR SPIKE. THE TIP IS WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13113021 ↗MalfunctionDec 14, 2021Break; Break
IT WAS REPORTED THAT UPON IMPACTION, THE KEEL PUNCH DRIVER BROKE INTO TWO PIECES WHERE THE RELEASE BUTTON IS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13004738 ↗MalfunctionSep 13, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE 12/14 -2 36MM ARTICULEZE TRIAL HEAD IS DAMAGED AND REQUIRES REPLACEMENT. ALSO LCS TIBIAL IMPACTOR AND KEEL PUNCH IMPACTOR. ALL DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12460712 ↗MalfunctionJul 20, 2021Break; Break
IT WAS REPORTED THAT THE MBT BLACK HANDLE WAS BROKEN DURING SURGERY. THE SCREW TO THE BUTTON WAS SNAPPED. ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12195558 ↗MalfunctionApr 26, 2021Break; Break
IT WAS REPORTED THAT THE TIBIAL KEEL PUNCH BROKE WHEN KEEL PUNCH WAS BEING DRIVEN DOWN INTO THE TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726199 ↗MalfunctionApr 12, 2021Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT WHILE PUTTING INSTRUMENTS TOGETHER, I FOUND THE SIGMA KEEL PUNCH HANDLE WAS MISSING THE SCREW AND SPRING. IT WAS TOGETHER IN THE SURGERY SO IT PROBABLY FELL APART IN DECON. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11652932 ↗MalfunctionNov 3, 2020Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BUTTON ON THE INSTRUMENT BROKE. IT DID NOT BREAK INTO 2 PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10778985 ↗MalfunctionSep 17, 2020Break; Break
IT WAS REPORTED THAT THE MBT KEEL PUNCH IMPACTOR'S BUTTON HAS FALLEN OFF THE IMPACTOR. THE SCREW THAT HELD IT IN PLACE WAS SHEARED OFF SO THERE IS NO LONGER ANY MECHANISM TO KEEP THE BUTTON ON THE IMPACTOR. IT WAS NOT USED ON A PATIENT AND IT WILL BE RETURNED TO DEPUY. THE METAL PORTION OF THE LINER TRIAL, THAT SCREWS INTO THE CUP, HAS LOST ITS WASHER THAT HOLDS IT INTO PLACE. THEREFORE THE METAL PORTION NO LONGER IS ATTACHED TO THE POLY PORTION OF THE LINER TRIAL. IT WAS NOT USED ON A PATIENT AND WILL BE RETURNED TO DEPUY. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10549240 ↗MalfunctionSep 15, 2020Component Missing; Component Missing
IT WAS REPORTED THAT THE MBT TIBIAL PREP HANDLE WAS MISSING THE LOCKING BUTTON UPON OPENING TRAYS. NO PIECES WERE LOST DURING THE CASE BUT DURING CLEANING IN SPD BEFORE THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10536605 ↗MalfunctionMay 21, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE WILL NOT LATCH WITH ENOUGH FORCE ENOUGH TO KEEL PUNCH TO REMOVE PUNCH AFTER TIBIAL PREP. THIS IS CHRONIC ISSUE. SURGICAL DELAY 30 SECONDS.
Patient problems: No Code Available; Not Applicable
MAUDE report 10080222 ↗MalfunctionJan 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PUNCH HANDLE WOULD NOT COMPLETELY SEAT IN EITHER PUNCH. ANOTHER WAS AVAILABLE AND THE SURGERY PROCEEDED AS PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9607909 ↗MalfunctionDec 26, 2019Device Slipped; Device Slipped
MalfunctionNov 5, 2019Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BUTTON OF THE IMPACTOR (P/N: (B)(4)) HAD ALREADY BEEN COME OFF WHEN IT'S DELIVERED FOR THE TKA SURGERY ON (B)(6), 2019. IT WAS CONSIDERED THAT THE SCREW WAS LOOSENED, AND THE BUTTON WAS COME OFF DURING TRANSPORTATION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9279407 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IT WON'T LOCK ON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240771 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IT WON'T LOCK ON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240770 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IT WON'T LOCK ON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240769 ↗MalfunctionOct 15, 2019Connection Problem; Device-Device Incompatibility; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT AFTER TRIALING, THE SURGEON TRIED TO REMOVE THE MBT KEEL PUNCH WITH THE HANDLE. THE HANDLE WOULD NOT STAY ATTACHED TO THE PUNCH. AFTER THE CASE, THEY TESTED THE HANDLE AND THE PUNCH. THE HANDLE DOES STAY ATTACHED TO ANY PUNCH. A SURGICAL DELAY OF 3 MINUTES.
Patient problems: No Code Available
MAUDE report 9192120 ↗MalfunctionJul 10, 2019Break; Break
IT DID NOT BREAK INTO 2 OR MORE PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8775744 ↗MalfunctionJun 5, 2019Break; Break
IT WAS REPORTED THAT THE MBT RELEASE MECHANISM FELL OUT. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8671205 ↗MalfunctionApr 5, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE PUNCH WOULD NOT STAY ATTACHED TO THE PUNCH HANDLE UPON REMOVAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8488979 ↗
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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