SIGMA HIGH PERFORMANCE 9505-02-047Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT KEEL PUNCH - CEMENTED SIZE 1.5-3 · Class 1
Quick summary
This DePuy Sigma High Performance femoral broach/keel punch is a surgical instrument used to shape the femur canal during hip replacement. The 33 reports mostly describe the punch not staying attached to its handle, connection points wearing out or deforming, and the tool becoming stuck in the bone, with no surgical delays noted. No deaths or injuries are reported. There are no recalls naming this device, and no reports came in during either the last 12 months or the 12 months before that.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295227632), received between Jul 7, 2017 and May 30, 2023 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (22 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility22
- Naturally Worn9
- Material Deformation5
- Connection Problem2
- Entrapment of Device2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient15
- Not Applicable11
- No Clinical Signs, Symptoms or Conditions6
- No Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY ALLEGATION AGAINST THE HANDLE? NO. B. WAS SURGERY TIME EXTENDED DUE TO A DEPUY SYNTHES PRODUCT? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO. C. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17018985 ↗MalfunctionAug 9, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE KEEL PUNCH WILL NO LONGER ATTACH TO HANDLE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192672 ↗MalfunctionJun 21, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL KEEL PUNCH WON'T STAY ON HANDLE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14753220 ↗MalfunctionMay 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE KEEL PUNCH WOULD NOT FIT ONTO THE FBT IMPACTOR. NOTHING BROKE OFF FROM THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14336758 ↗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 12769347 ↗MalfunctionSep 29, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE FBT CEMENTED SZ 1.5-3 KEEL PUNCH WAS DAMAGED ON THE BASE WHERE IT CONNECTS ONTO THE FBT BLACK HANDLE. NOTHING WAS BROKEN OFF FROM THE INSTRUMENT, BUT THE CONNECTION WAS DAMAGED/NOT FITTING ONTO THE HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12547008 ↗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 10222576 ↗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 10222575 ↗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 9859838 ↗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 9859836 ↗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 9859835 ↗MalfunctionJan 20, 2020Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE FBT CEMENTED 1.5-3 KEEL PUNCH DOES NOT CONNECT ONTO THE KEEL PUNCH IMPACTOR. THE CONNECTION ON THE BASE OF THE KEEL PUNCH WAS DAMAGED. NO PARTS WERE BROKEN OFF FROM THE INSTRUMENT. NO LOT NUMBER WAS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9607110 ↗MalfunctionSep 25, 2019Device-Device Incompatibility; 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 9117740 ↗MalfunctionSep 25, 2019Device-Device Incompatibility; 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 9117735 ↗MalfunctionSep 25, 2019Device-Device Incompatibility; 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 9117733 ↗MalfunctionSep 25, 2019Device-Device Incompatibility; 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 9117725 ↗MalfunctionSep 25, 2019Device-Device Incompatibility; 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 9117723 ↗MalfunctionSep 25, 2019Device-Device Incompatibility; 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 9117716 ↗MalfunctionAug 20, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE OFFICE SETS DOES NOT WORK. DEVICE WAS FOUND TO HAVE WEAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8912309 ↗MalfunctionAug 20, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE OFFICE SETS DOES NOT WORK. DEVICE WAS FOUND TO HAVE WEAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8912306 ↗MalfunctionJun 18, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT WHILE EXTRACTING THE TIBIAL KEEL PUNCH, THE FBT TIBIAL HANDLE WOULD NOT GRAB ONTO THE 1.5-3MM KEEL PUNCH. AFTER FURTHER EXAMINATION, IT WAS DETERMINED THAT THE BASE OF THE KEEL PUNCH WHERE IT CONNECTS TO THE HANDLE WAS DAMAGED. NOTHING WAS BROKEN OFF FROM THE INSTRUMENT. IT WAS DAMAGED TO NORMAL WEAR AND TEAR OF THE INSTRUMENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8707504 ↗MalfunctionJun 18, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT WHILE EXTRACTING THE TIBIAL KEEL PUNCH, THE FBT TIBIAL HANDLE WOULD NOT GRAB ONTO THE 1.5-3MM KEEL PUNCH. AFTER FURTHER EXAMINATION, IT WAS DETERMINED THAT THE BASE OF THE KEEL PUNCH WHERE IT CONNECTS TO THE HANDLE WAS DAMAGED. NOTHING WAS BROKEN OFF FROM THE INSTRUMENT. IT WAS DAMAGED TO NORMAL WEAR AND TEAR OF THE INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8707409 ↗MalfunctionApr 8, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT UPON REMOVAL OF THE CEMENTED FBT 1.5-3 KEEL PUNCH FROM THE TIBIAL BONE, THE CEMENTED FBT KEEL PUNCH WOULD NOT CONNECT INTO THE FBT HANDLE. AFTER FURTHER INSPECTION, IT WAS NOTICED THE CONNECTION POINT ON THE KEEL WHERE THEN HANDLE CONNECTS HAD BEEN DAMAGED. NO PIECES WERE BROKEN OFF FROM THE INSTRUMENT AND SURGICAL TIME WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8493230 ↗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 8321001 ↗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 8320997 ↗
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 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS HIGH PERFORMANCE 9505-02-011Depuy Orthopaedics, Inc. · PUNCH, SURGICAL30 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.