LCSRecalls & reported problems across all models
Depuy International Ltd · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of LCS by Depuy International Ltd in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2017 and Sep 11, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (18 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 LCS problems
Device problems
- Break18
- Device-Device Incompatibility3
- Mechanical Jam3
- Material Twisted/Bent2
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Difficult to Open or Close1
Patient problems
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions7
- No Information2
- Not Applicable2
- No Code Available1
LCS models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LCS 9505-01-219IMPACTOR23 reports
- LCS 9505-01-118INSTRUMENT, CUTTING, ORTHOPEDIC3 reports
- LCS 9505-01-227INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- LCS 9505-01-122TEMPLATE1 report
- LCS 9505-01-217TEMPLATE1 report
Recent LCS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Break; Break
IT WAS REPORTED THAT LCS MODULAR FEMORAL IMPACTOR IS BROKEN. NO FRAGMENTS WERE GENERATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031971 ↗MalfunctionMay 8, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT THE LCS FEMORAL IMPACTOR WAS BROKEN WHILE IMPACTING THE FEMORAL COMPONENT. THE PLASTIC PIECE SHEERED OFF FROM THE METAL BASE. THERE WERE NO FRAGMENTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21984637 ↗MalfunctionMar 28, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN IMPACTOR PRE OP. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21720029 ↗MalfunctionOct 4, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STYLUS WILL NO LONGER FIT IN THE CUTTING BLOCK. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536165 ↗MalfunctionSep 23, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOTTOM UPRIGHT ON THE INSTRUMENT THAT GRABS TOP UPRIGHT IS NO LONGER LOCKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12518098 ↗MalfunctionJun 9, 2021Break; Break
FEMORAL IMPACTOR HEAD BROKEN IN CONSIGNMENT INSTRUMENT SET. BROKEN INSTRUMENT RETURNED TO NSW LOAN SET WAREHOUSE FOR RETURN TO QUALITY. NO ADVERSE CONSEQUENCES AS ANOTHER IMPACTOR WAS USED. INSTRUMENT IS AVAILABLE FROM LOAN KITS NSW SEALED IN PEEL DOWN AND CLEARLY MARKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11969750 ↗MalfunctionNov 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
1. KINDLY CLARIFY WHY SOME INSTRUMENTATION WAS NOT DISASSEMBLED, WAS THERE ANY PRODUCT ISSUE OF THESE PRODUCTS? ¿ WHERE APPROPRIATE INSTRUMENTS THAT REQUIRE IT ARE DISASSEMBLED DURING THE INSPECTION PROCESS. IN THESE SPECIFIC CASES THE INSTRUMENTS ARE THEN REASSEMBLED AND PLACED BACK INTO THE TRAY AS THIS IS HOW THEY FIT INTO THE TRAYS. THEY ARE NOT SENT TO CUSTOMERS DISASSEMBLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10919343 ↗MalfunctionNov 18, 2020Break; Break
IMPACTING HEAD OF 950501219 NOTCH IMPACTOR HAS SNAPPED OFF FROM METAL RETAINING BASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10864315 ↗MalfunctionSep 17, 2020Break; Break
INSTRUMENT REPORTED AS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10546565 ↗MalfunctionAug 26, 2020Break; Break
LCS FEMORAL NOTCH IMPACTOR WAS DROPPED DURING CASE ON (B)(6) 2020. REPORTED BY CSSD TO BE BROKEN (B)(6) 2020. THIS DID NOT CAUSE ANY DELAYS IN SURGERY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10455567 ↗MalfunctionJul 9, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
(B)(6) HOSPITAL (B)(6) 2020; A CSSD TEAM MEMBER ADVISED THAT THE DISTAL CUTTING BLOCK WAS APPARENTLY A BIT STICKY DURING THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10251001 ↗MalfunctionMar 24, 2020Break; Break
MalfunctionMar 5, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam
IT WAS REPORTED THAT THE INSTRUMENT WON'T OPEN COMPLETELY AND IT STICKS. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9794427 ↗MalfunctionJan 27, 2020Break; Break
FEMORAL IMPACTOR AND FLATNESS GAUGE BROKE DURING SURGERY - 10 MINUTE DELAY TO SURGERY, NO ADVERSE OUTCOMES.
Patient problems: Not Applicable
MAUDE report 9633642 ↗MalfunctionDec 18, 2019Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam; Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam
STEINAMN PIN BENT AND STUCK INSIDE DIVERGENT PIN HOLE OF RIGHT TIBIAL CUTTING BLOCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9491040 ↗
Other Depuy International Ltd products
All Depuy International Ltd 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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