SIGMA LCS 9505-02-089Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE THREADED PINS HEADED · Class 1
All models of SIGMA LCS (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These are DePuy SIGMA LCS threaded pins, orthopedic surgical instruments used to hold bone parts in place during hip surgery. The 34 reports mostly describe pins breaking, bending, getting stuck in sizing guides or cutting blocks, and packs arriving with pins missing. None of the reports describe a death or an injury, and 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295227922), received between Sep 1, 2017 and Jan 24, 2025 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (20 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break20
- Device-Device Incompatibility10
- Difficult to Remove4
- Mechanical Jam4
- Physical Resistance/Sticking4
- Detachment of Device or Device Component3
- Entrapment of Device2
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient13
- No Clinical Signs, Symptoms or Conditions9
- No Information6
- Not Applicable4
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE PIN PACK WAS MISSING THE 2 X THREADED HEADED AND 2 X THREADED HEADLESS PINS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229579 ↗MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE PIN PACK WAS MISSING THE 2 X THREADED HEADED AND 2 X THREADED HEADLESS PINS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229546 ↗MalfunctionOct 17, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT, PIN WAS DAMAGED DURING IMPLANTATION NO DELAY TO SURGERY. SURGEON PLACED SCREW ONTO POWER TO INSERT INTO FEMORAL COMPONENT. WHEN ATTEMPTING TO PLACE SCREW INTO COMPONENT IT WAS CLEAR THERE WAS A BEND IN THE SCREW PREVENTING A STRAIGHT ENTRY POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470135 ↗MalfunctionJan 16, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED: THE THREADED PIN GOT STUCK IN THE SIZING GUIDE WITH THE LOT NO, WHICH CANNOT BE VISIBLE TO RECORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18519348 ↗MalfunctionSep 14, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT PINS BENT THROUGH WEAR AND TEAR. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO DID THE EVENT HAPPEN DURING A PROCEDURE? YES WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO EVENT OUTCOME/HOW WAS IT MANAGED? OTHER PINS ON SET USED WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES: 1 MINUTE HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO IS THE PRODUCT AVAILABLE FOR RETURN? NO PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: PINS BENT THROUGH WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17743488 ↗MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE WAS REPORTED FOR UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443232 ↗MalfunctionNov 29, 2022Break; Break
WHEN SCREWING IN THE SZ4 FEMORAL CUTTING BLOCK ONE OF THE THREADED HEADED PINS BROKE IN TWO. HALF WAS BERRIED BELOW THE CUT LINE OF THE DISTAL FEMUR THE OTHER PART CAME OF THE END OF THE DRILL. THE SURGEON HAD TO DIG IN TO THE FEMUR TO RECOVER THE BROKEN PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15878288 ↗MalfunctionSep 15, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT A THREADED PIN BECAME LODGED IN THE CUTTING JIG. THERE WAS MINIMAL DELAY TO THE OPERATION TIME AND NO CHANGE IN DIRECTION OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15429068 ↗MalfunctionAug 3, 2022Break; Break
IT WAS REPORTED THAT PIN BROKE IN THE CUTTING BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15157396 ↗MalfunctionJun 15, 2022Break; Entrapment of Device; Break; Entrapment of Device
DURING THE OPERATION, THE PIN BROKE AND REMAINED IN THE PATIENT'S BONE.
Patient problems: Insufficient Information
MAUDE report 14697681 ↗MalfunctionJan 27, 2020Difficult to Remove; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking
DURING THE CASE A PIN GOT STUCK ONTO A SIZE 5 SIGMA HP FEMORAL NOTCH GUIDE. THE THREADS ON THE PIN PREVENTED THE SCRUB NURSE TO DISENGAGE THE TWO ITEMS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9634633 ↗MalfunctionDec 16, 2019Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam; Physical Resistance/Sticking; Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam; Physical Resistance/Sticking
THE THREADED PIN GOT STUCK IN THE CUTTING BLOCK. ONE THEY COULD TAKE OUT BUT QUITE DEFORMED THE OTHER ONE WAS STUCK COMPLETELY.
Patient problems: Not Applicable
MAUDE report 9477002 ↗MalfunctionDec 16, 2019Material Twisted/Bent; Mechanical Jam; Physical Resistance/Sticking; Material Twisted/Bent; Mechanical Jam; Physical Resistance/Sticking
THE THREADED PIN GOT STUCK IN THE CUTTING BLOCK. ONE THEY COULD TAKE OUT BUT QUITE DEFORMED. THE OTHER ONE WAS STUCK COMPLETELY.
Patient problems: Not Applicable
MAUDE report 9476968 ↗MalfunctionDec 3, 2019Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility
INTRAOPERATIVELY IT WAS NOT POSSIBLE TO SEPARATE THE BOTH INSTRUMENTS. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT. ANOTHER INSTRUMENT WAS AVAILABLE AND USED WITHOUT ANY ISSUES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9401307 ↗MalfunctionNov 8, 2019Break; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking; Break; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking
IT WAS REPORTED THAT AFTER INSERTING A HEADED PIN THROUGH THE TC3 4 IN 1 BLOCK, THE PIN GOT STRUCK THROUGH THE BLOCK AND DISTAL SPACER AND COULD NOT BE REMOVED, BOTH DURING AND AFTER THE CASE. WITH 20 MINUTES SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 9297442 ↗MalfunctionNov 8, 2019Break; Entrapment of Device; Material Fragmentation; Break; Entrapment of Device; Material Fragmentation
DURING PKR SURGERY A THREADED HEADED PIN PRODUCT NUMBER LISTED ABOVE WAS USED TO SECURE A CUTTING JIG TO THE FEMORAL CONDYLE, DURING THE INSERTION OF THE PIN WITH A POWERED DRIVER, THE PINHEAD SHEERED OFF, LEAVING THE DISTAL THREADED PORTION OF THE PIN REMAINING IN THE CONDYLE. THE SURGEON WAS AWARE OF THE PIN SHEARING OFF AND HANDED THE PROXIMAL PORTION OF THE PIN TO THE SCRUB NURSE. THIS WAS THEN DISPOSED OF IN A SHARPS CONTAINER AS PER HOSPITAL POLICY. THE ACTION WAS TAKEN: IDENTIFICATION OF THE PROXIMAL PIN, FOLLOWED BY AN EXAMINATION OF THE PIN SITE. PATIENT RECOVERING AS EXPECTED. THERE WAS NO DELAY TO THE PROCEDURE, THE SURGERY CONTINUED AS PLANNED WITH A DIFFERENT PIN BEING USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9296906 ↗MalfunctionOct 15, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN GOT STUCK IN BLOCK. NO PIECES WERE BROKEN OFF CUTTING BLOCK. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9194700 ↗MalfunctionMar 15, 2019Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE SURGEON WAS DRIVING THE PIN INTO THE TC3 SIZE 4 CUTTING BLOCK AND THROUGH THE AUGMENT THE PIN BENT AND GOT BOUND UP BREAKING THE PIN HEAD OFF INTO THE PIN DRIVER AND BENDING THE PIN AT THE SAME TIME.
Patient problems: Not Applicable
MAUDE report 8425436 ↗MalfunctionAug 28, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS STATED THAT CROSS PIN STUCK IN SROM CUTTING BLOCK, UNIVERSAL HANDLE TIP FRACTURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7822029 ↗MalfunctionAug 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SURGEON WAS INSERTING A PIN IN THE TIBIAL CUT BLOCK. THE PIN BECAME STUCK DURING THE PROCESS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7808599 ↗MalfunctionJul 10, 2018Break; Break
THESE PINS ARE BROKEN AND WERE RECEIVED WITH (B)(4) WHICH DOES NOT HAVE THE PINS ON THE DER. PATIENT CONSEQUENCE?: UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673673 ↗MalfunctionJul 10, 2018Break; Break
THESE PINS ARE BROKEN AND WERE RECEIVED WITH (B)(4) WHICH DOES NOT HAVE THE PINS ON THE DER. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673662 ↗MalfunctionJul 10, 2018Break; Break
THESE PINS ARE BROKEN AND WERE RECEIVED WITH (B)(4) WHICH DOES NOT HAVE THE PINS ON THE DER. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673603 ↗MalfunctionJul 10, 2018Break; Break
THESE PINS ARE BROKEN AND WERE RECEIVED WITH (B)(4) WHICH DOES NOT HAVE THE PINS ON THE DER. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673586 ↗MalfunctionJul 10, 2018Break; Break
THESE PINS ARE BROKEN AND WERE RECEIVED WITH (B)(4) WHICH DOES NOT HAVE THE PINS ON THE DER. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673545 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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