LCS SIGMARecalls & reported problems across all models
Depuy (Ireland) · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,055
- Deaths reported
- 0
- Injuries reported
- 1,051
- Recalls
- 1
We found 15 models of LCS SIGMA by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 1,055 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 29, 2026 — classified as 1,051 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (532 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
LCS SIGMA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 22, 2021Terminated
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Z-1315-2021 · Root cause: Packaging change control · names 2 of these models · Recall details · FDA record ↗
Most reported LCS SIGMA problems
Device problems
- Loss of or Failure to Bond532
- Adverse Event Without Identified Device or Use Problem360
- Migration87
- Loose or Intermittent Connection50
- Insufficient Device Problem Information43
- Migration or Expulsion of Device28
- Appropriate Device Problem Term/Code Not Available13
- Loosening of Implant Not Related to Bone-Ingrowth12
Patient problems
- Pain398
- No Code Available354
- Insufficient Information134
- Unspecified Infection129
- Joint Laxity105
- Not Applicable88
- Swelling/ Edema46
- Loss of Range of Motion35
LCS SIGMA models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LCS SIGMA 1294-33-130Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall310 reports
- LCS SIGMA 1294-33-140Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall201 reports
- LCS SIGMA 1294-33-125Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing207 reports
- LCS SIGMA 1294-33-150Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing129 reports
- LCS SIGMA 1294-33-120Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing89 reports
- LCS SIGMA 1294-31-130Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing24 reports
- LCS SIGMA 1294-31-140Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing24 reports
- LCS SIGMA 1294-31-150Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing16 reports
- LCS SIGMA 1294-33-115Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing16 reports
- LCS SIGMA 1294-31-125Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing15 reports
- LCS SIGMA 1294-33-160Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing11 reports
- LCS SIGMA 1294-31-120Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing8 reports
- LCS SIGMA 1294-31-160Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- LCS SIGMA 1294-33-110Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- LCS SIGMA 1294-31-115Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
Recent LCS SIGMA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50934496 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to pain and stiffness.
Patient problems: Muscular Rigidity; Pain
MAUDE report 50179998 ↗InjuryAug 7, 2026Loss of or Failure to Bond
Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. (b)(6) is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysis.Reason for revision: Revision due to infection, pain, and debonded tibial component. The non-articular surface of the cemented tibial tray shows a minor retrieval artifact, sparse cement remaining, and relative motion between cement and metal although minor.
Patient problems: Pain; Unspecified Infection
MAUDE report 50176708 ↗InjuryMay 4, 2026Loss of or Failure to Bond
PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT INFECTED KNEE WITH LOOSENING. AFFECTED SIDE-LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25070556 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: PAIN.
Patient problems: Pain
MAUDE report 25026459 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.
Patient problems: Unspecified Infection
MAUDE report 24735199 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC INSTABILITY. AFFECTED SIDE-LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 24387645 ↗InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
REVISION OF LCS BEARING DUE TO INSTABILITY. THE BEARING THICKNESS NEEDED TO BE THICKER TO INCREASE STABILITY. BEARING WAS UPSIZED FROM 10MM TO 15MM. NO OTHER COMPONENTS WERE REVISED.
Patient problems: Joint Laxity
MAUDE report 24292031 ↗InjuryFeb 5, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) ON LEFT KNEE WITH THE PRODUCT IN QUESTION. POSTOPERATIVELY, LOOSENING WAS IDENTIFIED IN THE FEMORAL AND TIBIAL COMPONENTS, LEADING TO A REVISION TKA ON (B)(6) 2026. THE FEMORAL COMPONENT DETACHED EASILY UPON REMOVAL OF THE INSERT, AND SIGNIFICANT LOOSENING WAS ALSO OBSERVED IN THE TIBIAL TRAY, BOTH OF WHICH WERE REMOVED WITHOUT DIFFICULTY. THE REVISION WAS PERFORMED DUE TO FINDINGS OF LOOSENING AND SEVERE PAIN WITH EDEMA. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALTERNATIVE PRODUCTS, AND THERE WAS NO SURGICAL DELAY.
Patient problems: Pain; Swelling/ Edema
MAUDE report 24273915 ↗InjuryFeb 4, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THERE WAS A LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE, LOOSE TIBIAL COMPONENT. NO SURGICAL DELAY. ACTIVITY LEVEL - YES. DOI- UNKNOWN. DOR- UNKNOWN. AFFECTED SIDE- RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 24261791 ↗InjuryJan 22, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE LOOSENING OF THE TIBIA BASE PLATE DUE TO BONE CEMENT FAILURE. TIBIA AND POLY INSERT REMOVED AND REPLACED WITH REVISION COMPONENTS. IT WAS STATED THAT THE TIBIA BASE PLATE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT/IMPLANT. DOI: (B)(6) 2015 , DOR: UNKNOWN, AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information; Joint Laxity; Pain
MAUDE report 24151819 ↗InjuryJan 15, 2026Loss of or Failure to Bond; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions
MAUDE report 24085083 ↗InjuryJan 15, 2026Loss of or Failure to Bond
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO ADVERSE EFFECTS.
Patient problems: Joint Laxity
MAUDE report 24079851 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24071896 ↗InjuryDec 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
(B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR LOOSENING UNSPECIFIED. THE REVISED NON-ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS SEVERE ABRASION AND PITTING, AND MODERATE DELAMINATION AND CRACKING. THE ARTICULAR SURFACE SHOWS SEVERE PITTING AND MILD CRACKING.
Patient problems: Insufficient Information
MAUDE report 23924912 ↗
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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