LCS SIGMA 1294-33-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10603295025764), received between Aug 8, 2017 and Aug 7, 2026 — classified as 88 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (44 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 9, 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 INSTABILITY. POSTERIOR LATER WEAR ON INSERT. UNKNOWN LOT NUMBERS. SURGEON REMOVED FEMUR, TIBIA, INSERT.

  Patient problems: Joint Laxity

  MAUDE report 23756273 ↗
• InjuryNov 3, 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 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 LOOSE FEMORAL AND TIBIAL COMPONENTS. NON-ARTICULAR SURFACES SHOWS NO CEMENT REMAINING. CEMENT MANUFACTURER IS UNKNOWN. EXTENSIVE POLY DEBRIS NOTED AS WELL. TIBIAL INSERT SHOWS MODERATE YELLOWING.

  Patient problems: Insufficient Information

  MAUDE report 23456018 ↗
• InjuryNov 14, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA BETWEEN IMPLANT AND CEMENT INTERFACE. CEMENT MANUFACTURERS UNKNOWN. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20682947 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED PATIENT HARM AND SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 20555764 ↗
• InjuryOct 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOOSENING BETWEEN TRAY AND CEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20514171 ↗
• InjuryOct 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMORAL AND TIBIAL LOOSENING AT THE IMPLANT/CEMENT INTERFACE ON BOTH. THE CEMENT MANUFACTURER WAS UNKNOWN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20427285 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20401437 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS IS THIS EVENT RELATED TO THE STUDY DEVICE? NOT RELATED IS THIS EVENT RELATED TO THE STUDY PROCEDURE? REMOTE POSSIBILITY DATE OF EVENT: 28/AUG/2024. ADDITIONAL EVENT INFORMATION: CLINIC NOTE AD 5 SEP 2024 ON 08/28/2024, MEDICAL RECORDS NOTE THE PATIENT IS FOUR YEARS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS NOTED TO HAVE ARTHROFIBROTIC KNEE WITH PAIN AND STIFFNESS. THE PATIENT HAD A SCAR TISSUE SURGERY WITH OPEN RESECTION, POLY SWAP IN THE PAST. THE PATIENT THEN FELL AND HAD REGRESSION AND RETURN OF ARTHROFIBROSIS. THE PATIENT HAS INCREASED PAIN, DIFFICULT TIME WITH MOBILITY. AN ASPIRATION OF KNEE WAS PERFORMED AND NEGATIVE FOR ANY TIME OF BACTERIAL INFECTION. THE SURGEON SUGGESTED TOTAL KNEE ARTHROPLASTY REVISION FOR ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Fall; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 20223281 ↗
• InjuryAug 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT IN THE RIGHT KNEE. LOOSENING INTERFACE AND CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19991181 ↗
• InjuryJul 25, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR MIGRATION/LOOSENING. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: DEFINITELY. PROCEDURE RELATED: DEFINITELY NOT. DATE OF EVENT: 8/JUL/2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED. GEOGRAPHICAL LOCATION: US. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2024, MEDICAL RECORDS NOTE THE PATIENT WAS NOTED TO HAVE HAD SEVERAL FALLS. THE PATIENT IS EXPERIENCING PAIN, A LIMP, AND SWELLING. THE PATIENT HAS PSEUDOLAXITY, LARGE VARUS COLLAPSE AS WELL. RADIOLOGY REPORTS SHOW FAILURE OF TIBIAL TRAY WITH SUBSIDENCE. PHYSICAL EXAMINATION SHOWS A SIGNIFICANT EFFUSION, SIGNIFICANT PSEUDOLAXITY, LARGE VARUS COLLAPSE. FEMORAL COMPONENT APPEARS TO BE WELL FIXED AS WELL THE PATELLA IS TRACKING CENTRALLY, WITH NO TILT OR SUBLUXATION. THE PATIENT HAS LOOSE TIBIA WITH SUBSIDENCE.

  Patient problems: Ambulation or Postural Difficulties; Fall; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19827117 ↗
• InjuryMay 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. C. CAN YOU CONFIRM IF THE PATELLA WAS REVISED AND IF SO, WHAT WAS THE FAILURE? PATELLA WAS ADDED, NATURAL PATELLA WAS STILL INSITU.

  Patient problems: Discomfort; Pain

  MAUDE report 19374546 ↗
• InjuryFeb 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18788498 ↗
• InjuryJan 5, 2024Adverse 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18451656 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DEVICES ARE REMOVED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: DEC 13, 2023. AFFECTED SIDE: LEFT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18386999 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PERIPROSTHETIC INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18248209 ↗
• InjuryNov 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. THE PATIENT'S SIGMA PRIMARY COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THERE WAS NO VISIBLE CEMENT ATTACHED TO THE UNDERSIDE OF THE MOBILE BEARING TIBIAL TRAY UPON REMOVAL AND INSPECTION. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18192457 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS . EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Muscular Rigidity

  MAUDE report 18160041 ↗
• InjurySep 14, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT WENT TO THE SURGEON DUE TO PAIN AND INSTABILITY OF THE LEFT KNEE. UPON PHYSICAL EXAM SURGEON NOTED INSTABILITY IN THE KNEE JOINT. X-RAY OF THE LEFT KNEE SHOWED SUBSIDENCE OF THE MEDIAL SIDE OF THE TIBIAL COMPONENT. DURING THE SURGERY IT WAS NOTED THAT THE FEMUR WAS WELL FIXED. THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT WAS FIXED TO THE BONE BUT NO CEMENT CAME OUT WITH THE TIBIAL COMPONENT. DEPUY CEMENT WAS USED. ATTUNE REVISION COMPONENTS WERE USED FOR THE SURGERY. ONCE COMPONENTS WERE IMPLANTED, IT WAS NOTED THAT THE KNEE WAS STABLE AND HAD GREAT RANGE OF MOTION. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17743909 ↗
• InjuryMay 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON AN UNKNOWN DAY IN (B)(6) 2023, THE PATIENT VISITED THE DOCTOR COMPLAINING OF PAIN. NO LOOSENING WAS OBSERVED IN THE X-RAY FINDINGS. ON (B)(6) 2023, LOOSENING OF THE IMPLANTS DUE TO DEBONDING WAS CONFIRMED BY OPEN WOUND. THE IMPLANTS WERE REVISED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16894473 ↗
• InjuryApr 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16772849 ↗
• InjuryMar 15, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. THE PATIENT HAS A HISTORY OF EVENTS RELATING TO BOTH THE LEFT AND RIGHT KNEES. LEFT KNEE. (B)(6) 2011: SUCCESSFUL LEFT TKA WAS COMPLETED WITH DEPUY SYNTHES IMPLANTS INCLUDING CEMENT X 2 AND PATELLA. (B)(6) 2017: XRAYS SHOW LEFT TKA IS "IN SOME VARUS." (B)(6) 2021 X-RAYS SHOW THE VALGUS ALIGNMENT OF THE LEFT KNEE. OSTEOLYSIS AND PROXIMAL MEDIAL CYST FORMATION ARE NOTED UNDER THE TIBIAL PROSTHESIS. (B)(6) 2022: XRAYS NOTE "UNCHANGED LEFT TILT AND SETTLING." (B)(6) 2022: LEFT KNEE REVISION IS PERFORMED FOR PAIN AND SWELLING. THE TIBIAL TRAY HAD SETTLED SEVERAL MILLIMETERS PER X-RAY PRIOR. INTRAOPERATIVELY, THE FEMORAL COMPONENT HAD SOME "BUBBLES" AROUND THE EDGE WITH ROCKING THE PROSTHESIS. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE. THE FEMORAL COMPONENT ALSO HAD SIGNS OF LOOSENING. A NONDISPLACED FRACTURE OF THE LATERAL FEMORAL CONDYLE WAS NOTED WHICH WAS TREATED WITH A PLATE AND SCREWS PRIOR TO THE REPLACEMENT OF THE FEMORAL COMPONENT. ALL COMPONENTS WERE REVISED WITH EXCEPTION OF THE PATELLA. (THIS REVISION WILL BE UPDATED AND REMAIN CAPTURED ON THIS PC (B)(4). (B)(4) 2022: PATIENT HAS A LEFT DVT IN THE LEFT DFV THAT IS TREATED WITH ORAL BLOOD THI

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16550481 ↗
• InjuryDec 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2013; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15983592 ↗