SIGMA HIGH PERFORMANCE 9505-02-048Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT KEEL PUNCH - CEMENTED SIZE 4-5 · Class 1
All models of SIGMA HIGH PERFORMANCE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma High Performance keel punch is a surgical instrument used to shape the bone at the knee during joint replacement. The 29 reports mostly describe the punch not fitting or staying attached to its handle, bending or cracking, and pieces of it shearing off, in some cases leaving the instrument stuck in the bone. No deaths and no injuries are described. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295227649), received between Aug 6, 2018 and Mar 24, 2022 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility18
- Difficult to Remove7
- Connection Problem6
- Material Deformation5
- Naturally Worn4
- Break2
- Entrapment of Device2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Not Applicable12
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions5
- No Code Available1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTOR CRACKED WHILE IMPACTING THE TIBIA. NO PIECES FELL OFF AND NO DELAY. THE KEEL PUNCH WOULD CONNECT PROPERLY TO THE IMPACTION HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13890952 ↗MalfunctionMar 19, 2022Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
IT WAS REPORTED THAT KEEL PUNCH WILL NOT CONNECT PROPERLY TO THE IMPACTOR HANDLE. THE KEEL PUNCH IS BENT. NO OTHER INFORMATION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13827111 ↗MalfunctionNov 8, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
QUESTION: WITH REGARDS TO THIS, PLEASE CONFIRM IF ANY OF THE FOLLOWING INFORMATION IS AVAILABLE: A. PLEASE VERIFY WHAT DO YOU MEAN BY DAMAGED? WAS IT BROKEN, BENT, STRIPPED, OR CRACKED? RESPONSE: IT WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12769346 ↗MalfunctionJun 8, 2021Break; Break
THE KEEL PUNCH FBT CEMENTED WAS REPORTED DUE TO PIECE THAT SHEARED OFF ONE OF THE FINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11958078 ↗MalfunctionMay 20, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE KEEL PUNCH WON'T STAY ON INSERTER HANDLE. LOT NUMBER COULD NOT BE DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11859906 ↗MalfunctionJul 16, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE KEEL PUNCH WILL NOT STAY ON BLACK IMPACTOR HANDLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283176 ↗MalfunctionJul 2, 2020Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE DID NOT STAY ATTACHED TO THE PUNCH RESULTING IT REMAINS STUCK IN THE BONE.
Patient problems: Not Applicable
MAUDE report 10222580 ↗MalfunctionJul 2, 2020Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE DID NOT STAY ATTACHED TO THE PUNCH RESULTING IT REMAINS STUCK IN THE BONE.
Patient problems: Not Applicable
MAUDE report 10222579 ↗MalfunctionMar 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
KEEL PUNCHES AND HANDLES DISENGAGE LEAVING THE PUNCHES IN THE BONE UNABLE TO RETRIEVE WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 1, ACTION TAKEN WHEN EVENT OCCURRED? USED OSTEOTOME TO RETRIEVE, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: Not Applicable
MAUDE report 9859843 ↗MalfunctionMar 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
KEEL PUNCHES AND HANDLES DISENGAGE LEAVING THE PUNCHES IN THE BONE UNABLE TO RETRIEVE WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 1, ACTION TAKEN WHEN EVENT OCCURRED? USED OSTEOTOME TO RETRIEVE, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: Not Applicable
MAUDE report 9859839 ↗MalfunctionMar 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
KEEL PUNCHES AND HANDLES DISENGAGE LEAVING THE PUNCHES IN THE BONE UNABLE TO RETRIEVE WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 1, ACTION TAKEN WHEN EVENT OCCURRED? USED OSTEOTOME TO RETRIEVE, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: Not Applicable
MAUDE report 9859837 ↗MalfunctionSep 25, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ALL KEEL PUNCHES DID NOT CONNECT TO KEEL HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117637 ↗MalfunctionSep 25, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ALL KEEL PUNCHES DID NOT CONNECT TO KEEL HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117636 ↗MalfunctionSep 25, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ALL KEEL PUNCHES DID NOT CONNECT TO KEEL HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117635 ↗MalfunctionSep 25, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ALL KEEL PUNCHES DID NOT CONNECT TO KEEL HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117624 ↗MalfunctionSep 25, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ALL KEEL PUNCHES DID NOT CONNECT TO KEEL HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117619 ↗MalfunctionSep 25, 2019Difficult to Remove; Connection Problem; Device-Device Incompatibility; Difficult to Remove; Connection Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ALL KEEL PUNCHES DID NOT CONNECT TO KEEL HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117605 ↗MalfunctionApr 29, 2019Unintended Movement; Unintended Movement
CONNECTION BETWEEN THE INSERTER AND KEEL PUNCH IS BECOMING LOOSE. NO IMPACT TO PATIENT. SOME DELAY IN THE SURGERY.
Patient problems: Not Applicable
MAUDE report 8561973 ↗MalfunctionMar 4, 2019Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE HANDLE AND THE BROACH WERE NOT HOLDING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8387082 ↗MalfunctionFeb 13, 2019Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE TIBIAL PUNCH DID NOT CONNECT TO TIBIA PUNCH HANDLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8336096 ↗MalfunctionFeb 11, 2019Naturally Worn; Naturally Worn
TOO WORN TO HOLD STEM OR TO HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8326340 ↗MalfunctionFeb 8, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT IS TOO WORN TO HOLD STEM OR TO HANDLE.
Patient problems: Not Applicable
MAUDE report 8321095 ↗MalfunctionFeb 8, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT IS TOO WORN TO HOLD STEM OR TO HANDLE.
Patient problems: Not Applicable
MAUDE report 8321088 ↗MalfunctionFeb 8, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT IS TOO WORN TO HOLD STEM OR TO HANDLE.
Patient problems: Not Applicable
MAUDE report 8321063 ↗MalfunctionFeb 8, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT IS TOO WORN TO HOLD STEM OR TO HANDLE.
Patient problems: Not Applicable
MAUDE report 8320986 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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