LCS SIGMA 1294-33-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 310 adverse event reports that list this exact device (DI 10603295025788), received between Jun 26, 2017 and Sep 29, 2026 — classified as 309 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (165 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 310 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA . UNSURE OF DATE OF ORIGINAL SURGERY AND HOSPITAL LOCATION. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23646176 ↗
• InjuryNov 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE (B)(6) AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS THE REASON FOR THE REVISION WAS DUE TO LOOSE TIBIA AND FRAGMENTED PATELLA - MISSING MATERIAL ON THE LATERAL CORNER OF THE POLYETHYLENE BUTTON. NON-ARTICULAR SURFACE OF THE TIBIAL TRAY SHOWS NO CEMENT REMAINING. UNKNOWN CEMENT MFG.

  Patient problems: Insufficient Information

  MAUDE report 23468809 ↗
• InjuryNov 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 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 DUE TO LOOSE FEMORAL, LOOSE TIBIAL TRAY, LOOSE PATELLA, AND PAIN. UNKNOWN LOOSENING INTERFACES OR CEMENT MFG.

  Patient problems: Pain

  MAUDE report 23463199 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 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 DUE TO TIBIAL LOOSENING, FEMORAL OSTEOLYSIS, INSTABILITY, AND PAIN. THE NON-ARTICULAR SURFACE OF THE TIBIAL TRAY NO CEMENT REMAINING.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 23458254 ↗
• InjurySep 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF SIGMA SIZE 3 ROTATING PLATFORM TIBIAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE LOT NUMBER IS NOT AVAILABLE. DOI: (B)(6) 2008. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22961573 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 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: THE SIGMA FEMORAL COMPONENT, TIBIAL INSERT, AND TIBIAL TRAY WERE REVISED FOR POLYWEAR, OSTEOLYSIS, AND INSTABILITY.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 22685474 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE OLD FEMORAL IMPLANT HAD BECOME INFECTED. THERE WAS LOOSENING OF THE FEMUR AND TIBIAL IMPLANTS AT THE BONE/CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOCTOR REMOVED OLD IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22072242 ↗
• InjuryMay 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE; DEPUY CEMENT WAS USED. DOI: UNKNOWN DOR: (B)(6), 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21996253 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INCREASED PAIN, REDNESS, AND MILD ERYTHEMA. IV ANTIBIOTICS WAS STARTED FOR TREATMENT OF POSSIBLE CELLULITIS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cellulitis; Erythema; Pain

  MAUDE report 21996116 ↗
• InjuryMay 1, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER IS UNKNOWN. THE PATIENT EXPERIENCED TIBIAL IMPLANT COLLAPSED INTO VARUS DUE TO WEIGHT. THE PATIENT WAS REVISED AND THE LCS METAL BACK PATELLA REMAINED WITH THE POLY BUTTON BEING EXCHANGED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21943723 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT HIP REPLACEMENT DUE TO INFECTION. A WASHOUT WITH HEAD BALL AND LINER EXCHANGE WAS PERFORMED WITHOUT INCIDENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21855053 ↗
• InjuryFeb 19, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL BASEPLATE AT CEMENT TO IMPLANT INTERFACE WHICH HAD SUBSIDED. CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21416008 ↗
• InjuryJan 17, 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 TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT WHEN REMOVING THE TRAY, THERE WAS NO CEMENT ON THE IMPLANT. THE INSERT HAD SIGNS OF WEAR ON THE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21182183 ↗
• InjuryDec 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED FOR KNEE IMPLANT REMOVAL. DOI: UNKNOWN . DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20882469 ↗
• InjuryDec 3, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE ORIGINAL PROCEDURE WAS RIGHT TOTAL KNEE AND WAS PERFORMED ON (B)(6) 2021. IN (B)(6) 2024 THE PATIENT REPORTED PAIN AND WAS GIVEN A CORTICOSTEROID INJECTION. IN (B)(6) 2024, THE PATENT CONTINUED TO EXPERIENCE PAIN. BONE SCAN SHOWED SIGNIFICANT UPTAKE AROUND THE TIBIAL COMPONENT. MODERATE KNEE SWELLING. X-RAYS ALSO SHOWED THE TIBIAL COMPONENT HAD COLLAPSED INTO VALGUS. REVISION WAS RECOMMENDED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE TIBIA WAS LOOSE, THERE WAS LITTLE POLY WEAR, AND CEMENT USED WAS UNKNOWN. IT WAS UNKNOWN AS TO WHY THE COMPONENT WAS LOOSE. THERE WAS NO SIGNS OF INFECTION. TWO IMPLANTS WERE REMOVED ON (B)(6) 2024. NO COMPLICATION OR EXTENDED TIME IN OPERATION. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20835398 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RIGHT KNEE WAS REVISED ON (B)(6) 2024, DUE TO TIBIAL LOOSENING BETWEEN CEMENT AND IMPLANT. CEMENT MANUFACTURERS ARE UNKNOWN. DATE OF IMPLANT WAS (B)(6) 2013.

  Patient problems: Insufficient Information

  MAUDE report 20666589 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE JOINT EXPLANT DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20577394 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS: CLINICAL ADVERSE EVENTS RECEIVED FOR CONTINUED PAIN, PINCHING SENSATION, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: REMOTE POSSIBILITY, DATE OF EVENT: 8/OCT/2024, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL EXPLORATION OF THE FEMUR AND DEBRIDEMENT OF THE FAT PAD. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 129433130, LOT ID: 9744770,, COMPONENT TYPE: TIBIAL, DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG ID: 940023, LOT ID: J50C75, COMPONENT TYPE: FEMORAL, DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 RT. CATALOG ID: 960101, LOT ID: D20101506, COMPONENT TYPE: PATELLAR, DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM. CATALOG ID: 3322020, LOT ID: 9524034, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020, LOT ID: 9448053, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 196192034, LOT ID: 9137529, COMPONENT TYPE: INSERT, DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 17.5MM. THE PATIENT STATUS POST: RIGHT KNEE REPLACEMENT/REVISION KNEE RE

  Patient problems: Discomfort; Numbness; Pain; Paresthesia

  MAUDE report 20558640 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -YES, REVISION TKA SURGERY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 20521565 ↗
• InjuryOct 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A SURGERY VIA TKA FOR THE RIGHT KNEE. AFTER THE SURGERY, UNKNOWN DEFECT OCCURRED. ADDITIONAL EVENT INFORMATION PROVIDED BY SALES REP STATES THAT THE TIBIA IMPLANTS WERE SHOWN BY X-RAYS. ONLY THE TIBIA IMPLANTS ARE PLANNED TO BE REPLACED. THE DATE OF A REVISION SURGERY HAS NOT BEEN DECIDED YET.

  Patient problems: Insufficient Information

  MAUDE report 20507318 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR SPIN OUT DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: NOT RELATED DATE OF EVENT: 13/AUG/2024. DEVICE LOCATION: LEFT ADDITIONAL EVENT INFORMATION: ON 08/29/2024 MEDICAL RECORDS NOTE THE PATIENT HAS A HISTORY OF KNEE PAIN IN THE PATELLOFEMORAL LIGAMENT MEDIAL TO THE PATELLA. A SMALL BAND OF SCAR TISSUE IS PALPABLE. RADIOGRAPHS NOTE A WELL -PLACED ROTATING PLATFORM KNEE. THE SURGEON IMPRESSION IS OF A FIBROUS BAND OF TISSUE THAT IS BOTHERING THE PATIENT. THE SURGEON INJECTED THE KNEE WITH DEXAMETHASONE AND LIDOCAINE TO ADDRESS PAIN.

  Patient problems: Adhesion(s); Fibrosis; Pain

  MAUDE report 20230706 ↗