LCS SIGMA 1294-33-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 10603295025795), received between Jun 23, 2017 and Aug 7, 2026 — classified as 201 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (88 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Feb 22, 2021Class IITerminated

   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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 201 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH 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 PAIN. THE ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS MINOR YELLOWING.

  Patient problems: Pain

  MAUDE report 23923361 ↗
• InjuryDec 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH 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 OF THE FEMORAL COMPONENT, TIBIAL COMPONENT, AND PAIN. THE NON-ARTICULAR SURFACE OF THE REVISED CEMENTED TIBIAL TRAY SHOWS NO CEMENT REMAINING, AND RELATIVE MOTION BETWEEN BONE AND METAL. THE NON-ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS SEVERE ABRASION. THE ARTICULAR SURFACE DEMONSTRATES SEVERE ABRASION, PITTING, AND DELAMINATION.

  Patient problems: Pain

  MAUDE report 23923251 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH 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 ARTHROFIBROSIS. TIBIAL INSERT SHOWED MINOR YELLOWING.

  Patient problems: Adhesion(s)

  MAUDE report 23464569 ↗
• InjuryJul 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE SIGMA FEMORAL COMPONENT WAS REVISED FOR PAIN AND LOOSENING AT AN UNKNOWN INTERFACE. THE TIBIAL TRAY WAS REVISED FOR PAIN AND LOOSENING AT THE IMPLANT TO CEMENT INTERFACE AS NO CEMENT WAS REMAINING ON THE TRAY. THE PATELLA WAS REVISED FOR LOOSENING AT AN UNKNOWN INTERFACE, WEAR, AND PAIN.

  Patient problems: Pain

  MAUDE report 22666624 ↗
• InjuryMay 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH SOME PAIN IN HER KNEE. SURGEON BELIEVES THE PATIENT TO BE INFECTED BUT ONLY SUPERFICIAL. UPON OPENING THE JOINT, THA TIBIA WAS FOUND TO BE LOOSE. SURGEON REMOVED ALL IMPLANTS AND PLACED A SPACER USING AN ATTUNE RPPS POLY AND CEMENTED ATTUNE PS FEMUR UNTIL THE INFECTION CLEARS AND SURGEON CAN COME BACK TO REVISE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22115999 ↗
• InjuryMay 16, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. REVISION OF LCS COMPLETE TIBIA IMPLANTED IN 2016. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22036245 ↗
• InjuryMay 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AFTER KNEE SURGERY DUE TO LOOSENING. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22003737 ↗
• InjuryMay 7, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH 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 LOOSENING AND SUBSIDENCE OF TIBIAL AND FEMORAL COMPONENTS. FEMORAL COMPONENT WAS PRESSFIT. THERE WAS NO CEMENT ON THE TIBIAL COMPONENT. OSTEOLYSIS AND PAIN WERE ALSO REPORTED. UNKNOWN IF THE PATELLA WAS RESURFACED.

  Patient problems: Pain

  MAUDE report 21979616 ↗
• InjuryApr 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF SIGMA KNEE. REMOVED SIGMA SIZE 3 STAB FEMUR AND RP PRIMARY TRAY. THERE WAS LOOSENING OF THE SIGMA FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21936032 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. HE HAS SIGMA RP'S ON BOTH KNEES AND A SHOULDER REPLACEMENT AS WELL. ASPIRATION OF THE KNEE GREW C ACNES. PATIENT EXPERIENCING PAIN. SURGEON WAS REMOVING THE LEFT TKA TODAY AND REPLACING WITH A SPACER (ATTUNE CR FEMUR WITH ATTUNE CR RP INSERT CEMENTED INTO THE TIBIA). ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21253231 ↗
• InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A THE FEMUR REVISED IN 2017. THE PATIENT STRUGGLED WITH ROM. RECENTLY THE PATIENT FELT A POP AND DISCOMFORT. THE TIBIA WAS LOOSE AND WAS REVISED. THERE WAS A TIBIA LOOSENING AT CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER IS COMPETITOR. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 21208394 ↗
• InjuryJan 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. PATIENT HAD PAINFUL KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21150398 ↗
• InjuryDec 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (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 LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS (UNKNOWN INTERFACES). UNKNOWN CEMENT MFG. ECCENTRIC POLY WEAR WAS ALSO NOTED. THERE WAS YELLOWING OF THE TIBIAL INSERT NOTED.

  Patient problems: Insufficient Information

  MAUDE report 21026742 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: 20/JUN/2024. DATE OF ONSET: 20/JUN/2024 , OPERATIVE SIDE: RIGHT. DIAGNOSIS: CHRONIC INFECTION. ADVERSE EVENT: INFECTION - DEEP. SPECIFY: COUNTRY: US. SERIOUS: YES. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: REMOTE POSSIBILITY. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2021 , THE PATIENT WAS NOTED TO HAVE HAD A RIGHT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE FALLEN AND SUSTAINED A DISTAL FEMUR FRACTURE AND UNDERWENT ORIF OF THE DISTAL FEMUR FRACTURE. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAD RIGHT KNEE PAIN, STATUS POST TOTAL KNEE REPLACEMENT AND SUBSEQUENT ORIF OF DISTAL FEMUR FRACTURE. IT WAS NOTED THAT THE PATIENT CONTINUES TO HAVE INTERMITTENT CELLULITIS SINCE THE ORIF ON (B)(6) 2022. IT WAS NOTE THAT THE PATIENT HAD INTERMITTENT CELLULITIS. THE KNEE HAD BE ASPIRATED (B)(6) 2023, WHICH SHOWED A STAPH EPIDERMIDIS INFECTION. RADIOLOGICAL REPORT NOTES THE PATIENT HAS A RIGHT TOTAL KNEE ARTHROPLASTY WITH SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT. THE RIGHT KNEE WAS NOTED TO HAVE CHRONIC INFECTION.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 19709648 ↗
• InjuryJun 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO TIBIAL TRAY LOOSENING. THE LOOSENING OCCURRED AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Insufficient Information

  MAUDE report 19521203 ↗
• InjuryApr 29, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: LOOSE (UNKNOWN COMPONENT OR INTERFACE) AND PAIN.

  Patient problems: Pain

  MAUDE report 19203757 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INFECTION, TIBIAL INSERT SHOWED MODERATE YELLOWING AT REVISION

  Patient problems: Unspecified Infection

  MAUDE report 19166372 ↗
• InjuryApr 3, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  AESEPTIC LOOSENING OF SIZE 4 SIGMA MBT TIBIAL COMPONENT. TIBIA COLLAPSED MEDIALLY AND NEEDED TO BE REVISED. FEMUR WAS WELL FIXED BUT REMOVED DUE TO SURGEON WANTING TO CONVERT TO A FULL ATTUNE REVISION RATHER THAN SIGMA REVISION TIBIA COMPONENTS.

  Patient problems: Fall

  MAUDE report 19032277 ↗
• InjuryMar 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 18980438 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18979698 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. ON (B)(6) 2023, THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, LEFT KNEE. DEPUY COMPONENTS WERE IMPLANTED, INCLUDING DEPUY PATELLA, AND DEPUY CEMENT.

  Patient problems: Pain

  MAUDE report 18959827 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE) TREATMENT: PATIENT FITTED WITH AFO.

  Patient problems: Nerve Damage

  MAUDE report 18703512 ↗
• InjuryFeb 9, 2024Migration; Migration

  THE PATIENT WAS REVISED DUE TO RIGHT KNEE TIBIAL SUBSIDENCE. THERE WAS NO SURGICAL DELAY AND THE CEMENT BRAND WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18677272 ↗