SIGMA LCS HIGH PERFORMANCE 9505-02-015Recalls & reported problems
Depuy Orthopaedics, Inc. · SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 4-7 · Class 1
All models of SIGMA LCS HIGH PERFORMANCE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295227359), received between Jan 16, 2018 and Dec 29, 2021 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device-Device Incompatibility2
- Naturally Worn2
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Loose or Intermittent Connection1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE MBT HANDLE NO LONGER CONNECTS TO KEEL PUNCH OR SPIKE. TIP IS WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13111513 ↗MalfunctionSep 3, 2020Break; Break
IT WAS REPORTED THAT THE TOP OF PUNCH APPEARS TO BE OUT OF TOLERANCE AND DOES NOT FIT INTO POLY TRIAL. POLY TRIAL DEBRIS WAS CREATED WHEN FORCED INTO POSITION. A SURGICAL DELAY OF FIVE MINUTES.
Patient problems: No Code Available
MAUDE report 10489557 ↗MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility
DOES NOT STAY ON HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9233084 ↗MalfunctionDec 17, 2018Break; Break
BROKEN ATTACHMENT AT KEEL-PUCH IMPACT CONNECTION SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8169871 ↗MalfunctionJul 31, 2018Crack; Crack
IT WAS REPORTED THAT THE BOTTOM TAB WAS FOUND TO BE CRACKED PRIOR TO SURGERY. THE PIECE WAS NOT USED AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7735854 ↗MalfunctionApr 18, 2018Naturally Worn; Naturally Worn
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 7440479 ↗MalfunctionFeb 12, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
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 7262920 ↗MalfunctionJan 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE INSERTION POINT WHERE HANDLE ATTACHES WAS BROKEN UPON INITIAL USE. THE BROKEN PIECE WAS THROWN AWAY BY STAFF. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7193255 ↗
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