SIGMA LCS HIGH PERFORMANCERecalls & reported problems across all models
Depuy (Ireland) · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 203
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of SIGMA LCS HIGH PERFORMANCE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 203 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2017 and Sep 25, 2026 — classified as 1 injury, 202 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (86 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 LCS HIGH PERFORMANCE problems
Device problems
- Device-Device Incompatibility86
- Break36
- Failure to Cut36
- Naturally Worn19
- Dull, Blunt16
- Material Deformation10
- Physical Resistance/Sticking8
- Material Twisted/Bent7
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- No Consequences Or Impact To Patient63
- Insufficient Information20
- No Code Available9
- Not Applicable4
- No Information3
- No Known Impact Or Consequence To Patient2
SIGMA LCS HIGH PERFORMANCE models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SIGMA LCS HIGH PERFORMANCE 9505-02-071INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT137 reports
- 61 reports
- 2 reports
- 1 report
- SIGMA LCS HIGH PERFORMANCE 9505-02-025INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- SIGMA LCS HIGH PERFORMANCE 9505-02-302ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent SIGMA LCS HIGH PERFORMANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903850 ↗MalfunctionSep 24, 2026Break; Device-Device Incompatibility
It was reported that threaded pin broke and got stuck in sz 6 right cut through trial. Need to replace pin driver and cut through trial.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882680 ↗MalfunctionJul 30, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084666 ↗MalfunctionJul 28, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052083 ↗MalfunctionJun 12, 2026Material Deformation
IT WAS REPORTED THAT AN IM TIBIA DRILL WAS BENT. WHEN CONNECTED TO THE DRILL AND TURNED ON, THE BEND WOULD CAUSE THE DRILL TO SHAKE. DEVICE WAS DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491006 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT THE PIN DRIVER WAS BROKEN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506902 ↗MalfunctionJan 22, 2026Break
IT WAS REPORTED THAT THE PIN DRIVER HAD A BROKEN OFF PIN WEDGED INSIDE RENDERING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146672 ↗MalfunctionJan 22, 2026Failure to Cut
IT WAS REPORTED THAT DRILL IS DULL AND WILL NOT CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145752 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE PIN HEAD BROKEN OFF IN DRIVER DURING REMOVAL OF PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929695 ↗MalfunctionNov 5, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE THE PIN BROKE INSIDE THE PIN DRIVER. UNABLE TO TAKE THE BROKEN PIN INSIDE THE PIN DRIVER. USED ANOTHER SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480380 ↗MalfunctionAug 26, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PIN DRIVER COULD NOT SUCCESSFULLY ATTACH TO CORRECT POWER CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893166 ↗MalfunctionAug 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SPRING ON SPACER BLOCK IS DAMAGED AND PIN DRIVER WILL NOT HOLD PIN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771405 ↗MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN SNAPPED OFF INSIDE THE DRIVER AND COULD NOT BE TAKEN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22642974 ↗MalfunctionJul 22, 2025Break; Break
IT WAS REPORTED A CHIPPED DRILL WAS DISCOVERED. IT IS UNKNOWN WHEN THE EVENT OCCURRED.
Patient problems: Insufficient Information
MAUDE report 22565141 ↗MalfunctionJul 1, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT REAMER WAS DULL AND WILL NOT CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372451 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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