LCS 9505-01-219Recalls & reported problems
Depuy International Ltd · LCS HIGH PERFORMANCE FEMORAL NOTCH IMPACTOR · Class 1
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295225263), received between Aug 18, 2017 and Sep 11, 2025 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Scratched Material2
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
- Fracture1
- Naturally Worn1
- Unintended Movement1
Patient problems
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions6
- No Information2
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 23 most recent of 23 reports, 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 ↗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 ↗MalfunctionMar 24, 2020Break; Break
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 ↗MalfunctionNov 14, 2019Break; Break
A LARGE PIECE OF THE IMPACTING HEAD HAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9319796 ↗MalfunctionSep 9, 2019Break; Unintended Movement; Break; Unintended Movement
THE REP WAS CALLED THE DAY AFTER A TKR PROCEDURE TO BE TOLD THE FEMORAL NOTCH IMPACTOR HAD BROKEN. THE SCRUB NURSE SAID IT FELT A LITTLE LOOSE DURING SURGERY BUT AFTER SURGERY DURING DECONTAMINATION THE ENTIRE PLASTIC PART OF THE INSTRUMENT CAME AWAY FROM THE METAL. 1 X 950501219; LCS HP FEM NOTCH IMPACTOR; LOT NO: PG0109- AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8975488 ↗MalfunctionJul 24, 2019Scratched Material; Scratched Material
DAMAGED FEMORAL LCS IMPACTORS RETURNED FOR NICKS/SCRATCHES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8821548 ↗MalfunctionJul 24, 2019Scratched Material; Scratched Material
DAMAGED FEMORAL LCS IMPACTORS RETURNED FOR NICKS/SCRATCHES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8821546 ↗MalfunctionFeb 19, 2019Break; Break
IT WAS REPORTED THAT THE LCS HP FEM NOTCH IMPACTOR WAS BROKEN INTO 2 PIECES WHILE IMPACTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8349830 ↗MalfunctionJan 9, 2019Naturally Worn; Naturally Worn
IMPACTOR NEEDS REPLACED DUE TO GENERAL WEAR AND TEAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8231958 ↗MalfunctionMay 11, 2018Break; Break
TOTAL KNEE REPLACEMENT, FEMORAL COMPONENT WAS BEING IMPACTED AND SMALL BLACK CHIPS OF PLASTICS SPLINTERED OFF. NEW IMPACTOR OPENED. NO AE TO PATIENT, NO DELAY IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507127 ↗MalfunctionMar 28, 2018Break; Break
THE FEMORAL IMPACTOR WAS REPORTED WITH UNKNOWN REASON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7377760 ↗MalfunctionDec 7, 2017Fracture; Fracture
IT WAS REPORTED THAT THE LCS IMPACTOR WAS BROKEN WHEN THE (B)(6) STAFF TRANSPORTING THE TRAY. THE INSTRUMENT WAS NOT EVEN USED IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7096896 ↗MalfunctionNov 30, 2017Break; Break
SURGEON: DR. (B)(6). PROCEDURE: TOTAL KNEE REPLACEMENT. DURING IMPLANTING OF DEFINITIVE LCS FEMORAL (UN-CEMENTED) PROSTHESIS - WHICH REQUIRES SIGNIFICANT IMPACTION FORCE - THE BLACK PLASTIC IMPACTION HEAD OF THE NOTCH IMPACTOR BROKE AWAY FROM THE METAL BODY. ALL COMPONENTS RETRIEVED - COPIOUS LOVAGE ATTENDED TO IN CASE ANY DEBRIS REMAINING.... BUT NONE NOTED. ACTION TAKEN: TIBIAL IMPACTOR UTILISED. FEMORAL COMPONENT WAS FULLY SEATED USING THIS TOOL. NO AE TO PATIENT. A 1 MINUTE DELAY TO PROCEDURE. FEMALE PATIENT (B)(6), AGED (B)(6), DOB (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7070198 ↗MalfunctionNov 21, 2017Break; Break
IT WAS REPORTED THAT THE IMPACTING HEAD HAS BROKEN OFF THE IMPACTING BASE.
Patient problems: No Information
MAUDE report 7047939 ↗MalfunctionAug 18, 2017Break; Break
IT WAS REPORTED WHILE IMPACTING THE FEMORAL COMPONENT ONTO THE DISTAL FEMUR, SMALL PIECES BROKE OFF AND FELL AROUND THE IMPLANT AND INTO THE SURROUNDING TISSUE.
Patient problems: No Information
MAUDE report 6804245 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.