SIGMA 96-2341Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295242215), received between Sep 22, 2017 and Jul 15, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR WASH OUT OF KNEE AND POLY EXCHANGE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22505809 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FIRST STAGE REVISION FOR INFECTION. TC3 IMPLANTS INSITU WHICH WERE REMOVED AND A CEMENT SPACER REPLACED. REVISION WILL BE BOOKED ONCE INFECTION CLEARS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18785447 ↗
• InjuryDec 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT JUMPED THE POST AND DISLOCATED KNEE. I&D POLY EXCHANGE WAS DONE. PATIENT WENT TO A THICKER INSERT AND SEEMED TO HAVE RESOLVED THE ISSUE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 18269144 ↗
• InjuryOct 4, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE COMPLAINT CONCERNED THE IMPLANTS OF THE MOBILE TC3. MORE PRECISELY THE BREAKAGE OF THE "FEMORAL ADAPTER 5°" UNFORTUNATELY, THE ESTABLISHMENT COULD NOT PROVIDE THE BATCH NUMBER BUT WE READ THE NUMBER 718065. MAYBE IT IS THE BATCH NUMBER . ANOTHER ABNORMAL ELEMENT: THE METAL REINFORCEMENT OF THE POLYETHYLENE CAME OUT

  Patient problems: Fall

  MAUDE report 15537460 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PREVIOUS RIGHT TOTAL KNEE ARTHROPLASTY WAS CONVERTED TO A REVISION KNEE IN 2015. PATIENT COMPLAINED OF PAIN RECENTLY. SUSPECTED INFECTION. REMOVED POLY AND REPLACED WITH A NEW ONE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12578199 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE INFECTION. WASHOUT/POLY SWAP WERE PERFORMED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12281975 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CR SIGMA TKA AND MULTIPLE FIBROTIC THERAPIES PERFORMED. A REVISION TO A TC3 RP ON (B)(6) WAS DONE. THERE WAS SUSPECTED LOOSENING OF THE TC3 RP CONSTRUCT AND LACK OF EXTENSION. THE TIBIA WAS NOT GROSSLY LOOSE. THE IMPLANTS WERE REMOVED AND A RECUT WAS DONE TO ALLOW FULL EXTENSION. A NEW MBT TRAY WAS IMPLANTED AND THERE WAS FULL EXTENSION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12084913 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS BILATERAL INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11948035 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. WASH OUT WITH POLY EXCHANGED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9849217 ↗
• InjuryJan 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: (B)(6) 2017; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9629103 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. IT WAS REPORTED THAT THIS PATIENT HAD A KNEE REVISION LAST (B)(6) 2019 WHERE HIS SURGEON USED A SIGMA TC3 REVISION SYSTEM. ACCORDING TO HIS SURGEON THAT PATIENT CAME AND SEEN HIM SOMETIME AGO BECAUSE SHE WAS STILL EXPERIENCING PAIN AND INSTABILITY IN PATIENT LEFT KNEE. AFTER EVALUATION SURGEON DETERMINES THAT HER KNEE WAS TIGHT IN EXTENSION AND LOOSE IN FLEXION. SURGEON EXPLANTS THE PATIENTS TC3 FEMUR, FEMORAL ADAPTOR , NEUTRAL BOLT, UNIVERSAL STEM, AND TC3 INSERT. HE UPSIZED THE FEMUR TO HELP TIGHTEN THE FLEXION GAP AND UTILIZED A SLEEVE AND OFFSET BOLT TO FURTHER HELP MANAGE THE LOOSE FLEXION GAP. AFTER DOING A TRIAL REDUCTION THE PATIENT WAS STABLE IN FLEXION AND EXTENSION. THE PATIENTS TIBIA IMPLANTS WERE ALL LEFT IN SITU AND WERE NOT REVISED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9532176 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS ACUTE INFECTION. THE SURGEON PERFORMED POLY SWAP AND PUT A STIMULAN BEADS TO TREAT THE INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN AFFECTED KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9340981 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8390336 ↗
• InjuryOct 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS ACTIVE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6941837 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6887198 ↗