SIGMA LCS HIGH PERFORMANCE 9505-02-011Recalls & reported problems
Depuy Orthopaedics, Inc. · SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 2-3 · Class 1
All models of SIGMA LCS HIGH PERFORMANCE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma LCS High Performance keel punch is a surgical instrument used to shape the bone during knee replacement surgery. The 30 adverse event reports mostly describe metal parts breaking off — connection tabs, feet and small tines — as well as dull blades that fail to cut, with twisted or bent shafts and loose connections also mentioned. No deaths and no injuries were reported, and no reports describe harm to the patient. There are no recalls naming 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295227311), received between Sep 20, 2017 and Dec 9, 2022 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (19 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 18, 2026.
Most reported problems
Device problems
- Break19
- Appropriate Device Problem Term/Code Not Available4
- Device-Device Incompatibility3
- Failure to Cut3
- Loose or Intermittent Connection3
- Material Twisted/Bent3
- Naturally Worn2
Patient problems
- No Consequences Or Impact To Patient18
- No Clinical Signs, Symptoms or Conditions9
- No Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2022Break; Break
IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15951408 ↗MalfunctionDec 9, 2022Break; Break
IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15951265 ↗MalfunctionOct 3, 2022Break; Break
IT WAS REPORTED THAT THE CONNECTION FOR HANDLE ATTACHMENT IS BROKEN OFF ON BOTH ITEMS. NO LOOSE ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15527360 ↗MalfunctionApr 22, 2022Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT DEVICE WAS BROKEN AND DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189243 ↗MalfunctionApr 22, 2022Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT DEVICE WAS BROKEN AND DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189200 ↗MalfunctionApr 22, 2022Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT DEVICE WAS BROKEN AND DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189198 ↗MalfunctionApr 11, 2022Break; Break
IT WAS REPORTED THAT THE CONNECTION TABS ARE BROKEN OFF A REPEATING PROBLEM REPORTED PREVIOUSLY ON THE ITEM. NO LOOSE PARTS. NO PARTS REMAINING IN PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074116 ↗MalfunctionJan 14, 2022Break; Break
UPON IMPACTING THE KEEL INTO THE TIBIA ONE OF THE FEET THAT ATTACHES THE KEEL TO THE HANDLE BROKE OFF OF THE KEEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13261931 ↗MalfunctionFeb 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
PUNCH WON¿T ACCEPT HANDLE. CUP INSERTER WON¿T CLAMP DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11358654 ↗MalfunctionNov 13, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED STATED THAT ONE OF THE LIPPED FLANGES THAT GRIP THE PUNCH TO THE HANDLE BROKE OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10837708 ↗MalfunctionJul 1, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT IS WAS REPORTED THAT THE FEMORAL IMPACTORS ARE DAMAGED AND THE 2.3 MBT KEEL PUNCH DOES NOT FIT HANDLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10217812 ↗MalfunctionOct 14, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE PUNCH IS WORN OUT. THE CUT OUT ON THE PUNCH WHERE THE HANDLE ATTACHES IS ROUNDED FROM WEAR AND TEAR. IT DOES NOT ATTACH WELL TO THE MBT HANDLE. DURING THE CASE, IT TOOK MULTIPLE ATTEMPTS FOR THE SURGEON TO REMOVE THE PUNCH AFTER TRIALING. 2 MINUTES SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 9186567 ↗MalfunctionApr 4, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE METAL POST AT THE KEEL IMPACT ATTACHMENT SITE GRADUALLY BENDS, CRACKS AND BREAKS OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8482575 ↗MalfunctionApr 4, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE METAL POST AT THE KEEL IMPACT ATTACHMENT SITE GRADUALLY BENDS, CRACKS AND BREAKS OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8482569 ↗MalfunctionApr 4, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE METAL POST AT THE KEEL IMPACT ATTACHMENT SITE GRADUALLY BENDS, CRACKS AND BREAKS OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8482567 ↗MalfunctionJan 23, 2019Break; Break
BROKEN METAL AT THE PUNCH-HANDLE ATTACHMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8271350 ↗MalfunctionDec 4, 2018Break; Break
MalfunctionAug 30, 2018Break; Break
METAL PART BROKE OFF AT THE HANDLE ATTACHMENT SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7832350 ↗MalfunctionJul 23, 2018Break; Break
IT WAS REPORTED THAT SEVERAL INSTRUMENT BROKE OR WERE NOT WORKING PROPERLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7710767 ↗MalfunctionApr 24, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PROBLEMS APPEARED GRADUALLY DUE TO WEAR OF THE POSTS ON THE KEEL PUNCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7453582 ↗MalfunctionMar 20, 2018Break; Break
PROBLEMS APPEAR GRADUALLY DUE TO WEAR OF THE POSTS ON THE KEEL PUNCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7352822 ↗MalfunctionMar 6, 2018Break; Break
IT WAS REPORTED THAT THE TIBIAL PREP BROKE WHILE IMPACTING. ALL PARTS RETRIEVED FROM PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7316022 ↗MalfunctionFeb 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROBLEMS APPEARED GRADUALLY DUE TO WEAR OF THE POSTS ON THE KEEL PUNCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7279910 ↗MalfunctionFeb 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED DUE TO WEAR OF THE POST ON THE KEEL PUNCHES, THE KEEL PUNCH IMPACTOR HANDLE SLIPS AND LOOSENS DURING SURGERY. IT GETS DIFFICULT TO REMOVE THE KEEL PUNCH WHEN FINISHED PREPARING TIBIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7279874 ↗MalfunctionFeb 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DUE TO WEAR OF THE POST ON THE KEEL PUNCHES, THE KEEL PUNCH IMPACTOR HANDLE SLIPS AND LOOSENS DURING SURGERY. IT GETS DIFFICULT TO REMOVE THE KEEL PUNCH WHEN FINISHED PREPARING TIBIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7279759 ↗
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 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 18, 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