SIGMA HIGH PERFORMANCERecalls & reported problems across all models
Depuy (Ireland) · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 111
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 13 models of SIGMA HIGH PERFORMANCE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Oct 24, 2025 — classified as 111 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (77 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SIGMA HIGH PERFORMANCE problems
Device problems
- Device-Device Incompatibility77
- Material Deformation15
- Naturally Worn14
- Connection Problem8
- Difficult to Remove7
- Material Twisted/Bent6
- Break5
- Material Discolored5
Patient problems
- No Consequences Or Impact To Patient56
- No Clinical Signs, Symptoms or Conditions25
- Not Applicable23
- No Code Available18
- Insufficient Information3
- No Information2
- No Known Impact Or Consequence To Patient1
SIGMA HIGH PERFORMANCE models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SIGMA HIGH PERFORMANCE 9505-02-047PUNCH, SURGICAL33 reports
- SIGMA HIGH PERFORMANCE 9505-02-048PUNCH, SURGICAL29 reports
- SIGMA HIGH PERFORMANCE 9505-02-051PUNCH, SURGICAL14 reports
- 12 reports
- SIGMA HIGH PERFORMANCE 9505-02-050PUNCH, SURGICAL10 reports
- SIGMA HIGH PERFORMANCE 9505-01-174INSTRUMENT, CUTTING, ORTHOPEDIC3 reports
- 2 reports
- SIGMA HIGH PERFORMANCE 9505-01-175INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- 2 reports
- 1 report
- 1 report
- 1 report
- 1 report
Recent SIGMA HIGH PERFORMANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIECES WERE NOT FITTING TOGETHER. THE EVENT DID NOT OCCUR IN A PROCEDURE. THERE WAS NO SURGEON INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378417 ↗MalfunctionAug 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
THE PIN HOLE IN THE BLOCK WOULD NOT ACCEPT THE APPROPRIATE PIN FOR FIXATION TO THE BONESURGERY WAS DELAYED 1 MINUTE DUE TO THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 20017255 ↗MalfunctionAug 20, 2024Device-Device Incompatibility; Device-Device Incompatibility
THE PIN HOLE IN THE BLOCK WOULD NOT ACCEPT THE APPROPRIATE PIN FOR FIXATION TO THE BONE SURGERY WAS DELAYED 1 MINUTE DUE TO THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 20003213 ↗MalfunctionMar 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA FOR THE LEFT KNEE JOINT WITH THE PRODUCT IN QUESTION. DURING SURGERY, THE STEINMANN PIN WAS STUCK IN THE DISTAL TEMPORARY FIXATION MEDIAL PIN HOLE OF THE PRODUCT IN QUESTION AND COULD NOT BE PULLED OUT. HOWEVER, THE SURGERY WAS PERFORMED AS IT WAS, AND THE PROCEDURE WAS NOT AFFECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18949682 ↗MalfunctionMar 8, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE PIN HOLE SEEMS TO BE DEFORMED IN THE BLOCK. THE APPROPRIATE PIN BECAME STUCK IN THE PIN HOLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? PULLED THE PIN AND BLOCK OUT TOGETHER AFTER MAKING THE RESECTION, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?-- NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY NO, (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: No Clinical Signs, Symptoms or Conditions
MAUDE report 18864820 ↗MalfunctionNov 15, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
THE PIN HOLE IN THE TIBIAL CUTTING BLOCK DEFORMED AND WOULD NOT ACCEPT THE APPROPRIATE PINS TO SECURE THE BLOCK TO THE BONE. PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18142571 ↗MalfunctionJun 5, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2023, THE TOWER IS BENT. THIS REPORT IS FOR A SIGMA HP FBT DRILL TOWER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17058300 ↗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 ↗MalfunctionMay 23, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING PRIMARY TOTAL KNEE ARTHROPLASTY, SMOOTH PIN GOT STUCK IN THE MINIMALLY INVASIVE LEFT 0 DEGREE CUTTING BLOCK. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16986851 ↗MalfunctionNov 16, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT 2 PIECES OF THE DISTAL FEMORAL CUTTING JIG HAVE BECOME STUCK AND WONT DISENGAGE EACH OTHER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15805848 ↗MalfunctionSep 19, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TINES ARE BENT INWARD CAUSING REAMER TO NOT FIT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445262 ↗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 ↗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 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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