SIGMA 96-2364Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295242536), received between Sep 5, 2018 and Feb 5, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24269262 ↗
• InjuryJul 30, 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, FEMORAL ADAPTOR AND TIBIAL INSERT WERE REVISED FOR INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22668675 ↗
• InjuryJul 23, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LEFT KNEE DUE TO INSTABILITY. TC3/MBT IN SITU, TC3 REMOVED AND S-ROM HINGE IMPLANTED. TC3 POLY WAS WORN AND POLY SPINE FRACTURED. SIZE 5 LEFT TC3 FEMORAL COMPONENT. NO ALLEGATIONS AGAINST THE TIBIAL TRAY.

  Patient problems: Joint Laxity

  MAUDE report 22580745 ↗
• InjuryMar 18, 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 PAIN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21634329 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT POLY SWAP FOR INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20630743 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TIBIA REVISED DUE TO PAIN AND SWELLING. TIBIAL LOOSENING WAS NOT OBSERVED. NO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2018, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18711163 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. I&D AND POLY SWAP PERFORMED. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 17754481 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D AND POLY EXCHANGE WERE DONE. LOT NUMBER FROM THE TIBIAL INSERT WAS NOT READABLE BECAUSE THE IMPLANT WAS DESTROYED DURING REMOVAL. NO SURGICAL DELAY. DOI: 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14518322 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6) HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12542229 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 RP POLY WASHOUT DUE TO INFECTION. IT WAS REPLACED OLD POLY WITH NEW POLY. DAIR PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11831239 ↗
• InjuryApr 26, 2021Noise, Audible; Noise, Audible

  OFFICE NOTES (B)(6) 201 - (B)(6) 2019 INDICATE THE PATIENT IS EXPERIENCING SWELLING, POPPING, INSTABILITY AND PAIN OF THE LEFT KNEE. HE IS ALSO EXPERIENCING SWELLING, PAIN, NUMBNESS AND INSTABILITY IN THE RIGHT KNEE AND FEELINGS OF CRUNCHING AND CRACKING. CURRENT TREATMENT INCLUDES ORAL PAIN MEDICATION, PHYSICAL THERAPY, KNEE BRACES AND NERVE BLOCKS. NO EVIDENCE OF ADDITIONAL REVISION OF PRODUCTS. DOI: (B)(6) 2018 (TRAY - CAPTURED IN (B)(4)), DOI: (B)(6) 2019 (FEMUR, PATELLA AND INSERT - CAPTURED IN (B)(4)), DOR: NONE REPORTED, LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11723906 ↗
• InjuryMar 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON STATED PATIENT'S KNEE WAS CONTRACTED. REMOVED POLY AND REPLACED WITH A SMALLER THICKNESS POLY. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 11536865 ↗
• InjuryJan 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT'S KNEE WAS REVISED DUE TO HUGENESS AND AN LPS INSERT WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNK, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11155636 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 10889609 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10028866 ↗
• InjuryNov 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO COMBATIVENESS RESULTING TO DISLOCATION WHILE IN POST ANESTHESIA CARE. IT WAS CONVERTED TO SROM HINGED KNEE. UNKNOWN BONE CEMENT WAS USED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9365033 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND A DEFICIENT MLL. PATIENT HAD A TC3 MBT KNEE WITH SIZE 5 LEFT TC3 FEMUR, 5 DEFREE ADAPTOR, T2/ 2 BOLT, 10 X 75 STEM, AND MBT TC3 5 X 17.5 INSERT REMOVED AND REPLACED WITH LEFT MEDIUM NOLES HINGE, 40 FULL POROUS SLEEVE, 18 X 75 STEM AND 14X MEDIUM LPS POLY. TIBIA WAS NOT REVISED. DOI: (B)(6) 2014. DOR: (B)(6) 2019, LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9167790 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. FEMUR WAS REVISED. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8535549 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENDING PRODUCT LIABILITY REPORTS: THE PATIENT UNDERWENT AN I&D AND POLY LINER EXCHANGE ON (B)(6) 2016 FOR INCREASED PAIN, SWELLING, AND POSSIBLE INFECTION DUE TO INCREASED WHITE BLOOD CELL COUNT THOUGH CULTURES WERE NEGATIVE. THE IMPLANT DATE WAS (B)(6) 2016.

  Patient problems: No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8317636 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INCREASED PAIN AND SWELLING.

  Patient problems: No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8289444 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TOTAL JOINT PROSTHESIS AND INSERTION OF ANTIBIOTIC SPACER DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8275671 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND POOR MOTION. THE SURGEON REMOVED AND REPLACED POLY INSERT AND ADDED A PATELLA COMPONENT.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8244425 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE STABLE. NO IMPLANTS WERE BROKEN DURING SURGERY SO NONE WERE NEEDED TO BE RETRIEVED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7845684 ↗