SIGMA LCSRecalls & reported problems across all models
Depuy (Ireland) · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 480
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 20 models of SIGMA LCS by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 480 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Jun 12, 2026 — classified as 1 injury, 479 malfunctions.
The most frequently reported specific device problem is “Break” (217 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 problems
Device problems
- Break217
- Device-Device Incompatibility71
- Material Twisted/Bent54
- Material Deformation42
- Naturally Worn26
- Mechanical Jam25
- Detachment of Device or Device Component18
- Appropriate Device Problem Term/Code Not Available16
Patient problems
- No Consequences Or Impact To Patient228
- No Clinical Signs, Symptoms or Conditions195
- No Information30
- Not Applicable15
- Insufficient Information14
- No Code Available6
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
SIGMA LCS models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SIGMA LCS 9505-01-230INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- SIGMA LCS 9505-01-305ORTHOPEDIC MANUAL SURGICAL INSTRUMENT65 reports
- SIGMA LCS 9505-01-229INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA LCS 9505-02-024IMPACTOR54 reports
- SIGMA LCS 9505-02-089ORTHOPEDIC MANUAL SURGICAL INSTRUMENT34 reports
- SIGMA LCS 9505-02-028ORTHOPEDIC MANUAL SURGICAL INSTRUMENT33 reports
- SIGMA LCS 9505-01-203INSTRUMENT, CUTTING, ORTHOPEDIC32 reports
- SIGMA LCS 9505-02-072ORTHOPEDIC MANUAL SURGICAL INSTRUMENT21 reports
- SIGMA LCS 9505-02-070ORTHOPEDIC MANUAL SURGICAL INSTRUMENT19 reports
- SIGMA LCS 9505-02-088ORTHOPEDIC MANUAL SURGICAL INSTRUMENT19 reports
- SIGMA LCS 9505-01-228INSTRUMENT, CUTTING, ORTHOPEDIC15 reports
- SIGMA LCS 9505-01-307TEMPLATE11 reports
- SIGMA LCS 9505-02-806TRAY, SURGICAL, INSTRUMENT10 reports
- SIGMA LCS 9505-01-207TEMPLATE8 reports
- SIGMA LCS 9505-02-006TEMPLATE2 reports
- SIGMA LCS 9505-02-029ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SIGMA LCS 9505-01-308HAMMER, SURGICAL1 report
- SIGMA LCS 9505-02-000TEMPLATE1 report
- SIGMA LCS 9505-02-003TEMPLATE1 report
- SIGMA LCS 9505-02-073ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent SIGMA LCS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IMPACTOR DEVICES WERE BROKEN DURING THE CASE. IT WAS REPORTED THAT ALL PARTS WERE REMOVED FROM STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491090 ↗MalfunctionJun 10, 2026Break
IT WAS REPORTED THAT DURING MDRD INSPECTION, IT WAS DISCOVERED THAT ONE OF THE SPIKES ON THE JIG HAD BROKEN OFF AND THEREFORE THE ITEM WAS NO LONGER FUNCTIONAL. PRODUCT HAS BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461117 ↗MalfunctionJun 1, 2026Material Deformation
IT WAS REPORTED THAT THE SHIM DEVICES WERE BROKEN, THE ALIGNMENT ROD WAS BENT AND THE TRIAL POST DEVICES WERE CRACKED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. THERE WAS NO PATIENT OR USER HARM. THERE WERE NO REPORTS OF SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351297 ↗MalfunctionMay 7, 2026Material Deformation
IT WAS REPORTED THAT THERE WERE BROKEN TRIAL SHIMS, BENT ALIGNMENT ROD, CRACKED TRIAL POST.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25110626 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT THE EM TIBIAL CUTTING GUIDE WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886494 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT THE SLAP HAMMER HANDLE HAS A TEAR IN THE RUBBER. ANOTHER INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745008 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT THE SPIKE TOP FELL OFF AND THE EM TIBIAL CUTTING GUIDE BROKE INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483631 ↗MalfunctionFeb 25, 2026Break
IT WAS REPORTED THAT WHEN IMPACTING AND SECONDARY IMPACTING THE RED KNOB BROKE OFF THE INTRODUCER AND THE SPRING IN THE SIGMA UNIVERSAL HANDLE BROKE. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446478 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, WHEN SECONDARY IMPACTING THE FEMORAL COMPONENT, THE SIGMA UNIVERSAL HANDLE WAS BROKEN. IT WAS REPORTED THAT ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397550 ↗MalfunctionDec 15, 2025Break; Break
UNIVERSAL HANDLE BROKE INTO THREE PIECES PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (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 23810322 ↗MalfunctionDec 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT PRIOR TO THE START OF SURGERY, THE ROD HAD BENT. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715734 ↗MalfunctionNov 4, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN INITIALLY IMPACTING THE FEMUR IMPLANT, THE RED KNOB BROKE OFF THE INTRODUCER. IT WAS REPORTED THAT THE SIGMA IMPACTOR UNIVERSAL HANDLE INSIDE BROKE AND WOULD NOT HOLD THE IMPACTOR TIP ON. ALL PIECES WERE REMOVED, AND NO HARM WAS DONE TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23472520 ↗MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT WHEN IMPACTING FEMURS, THE SIGMA IMPACTOR HANDLE BROKE INTO TWO OR MORE PIECES. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401806 ↗MalfunctionSep 10, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23015505 ↗MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THREADED PIN WAS WITHOUT STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22983569 ↗
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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