SIGMA 96-2334Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295242154), received between Dec 8, 2017 and Mar 25, 2026 — classified as 13 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A SIGMA TC3 LEFT KNEE REVISION DONE OVER 10 YEARS AGO. THE SURGEON DOES NOT HAVE THE RECORD FOR IT. BACK IN (B)(6) PATIENT FELL AND DISLOCATED THE TC3 POLY AND ON (B)(6) 2026 PATIENT'S TC3 POLY WAS REVISED TO A THICKER POLY. HOWEVER, THE PATIENT FELL AGAIN RECENTLY, DISLOCATING THE TC3 POLY AGAIN, SO THE SURGEON REVISED AGAIN BY REMOVING THE TC3 FEMUR, LEAVING THE SLEEVE AND STEM IN PLACE AND CEMENTED IN A SROM HINGE FEMUR WITH A THICKER POLY. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT KNEE. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES THE PREVIOUS REVISION PERFORMED ON (B)(6) 2026.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 24691320 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PATELLAR CLUNK IN TC3 CONSTRUCT. PATELLA TISSUE WAS REVISED. POLY WAS SWAPPED FROM 17.5 TO 20. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24524411 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR HO BONE. POLY WAS SWAPPED FOR A NEW ONE AT THE SAME SIZE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Extraskeletal ossification

  MAUDE report 20417738 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17756139 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D WITH POLY SWAP PERFORMED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13710464 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TP REPEAT INFECTION. SURGEON WASHED OUT KNEE WITH POLY EXCHANGE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11931454 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GLOBAL INSTABILITY. POLY EXCHANGED WAS PERFORMED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11372911 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON CONVERTED TC3 TO LPS DISTAL FEMUR DUE TO MCL DEFICIENCY AFTER A FALL. FEMUR AND FEMORAL ADAPTER AND BOLT WERE PUT IN 2015; INSERT WAS PLACED IN 2018. DOI: 2015 (FEMUR AND FEMORAL ADAPTER AND BOLT) AND 2018 (INSERT); DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9548504 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO GROSS INSTABILITY. INCREASED POLY FROM A 17.5MM TO A 25MM. DOI: (B)(6) 2009; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9540505 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND DECREASED IN THE RANGE OF MOTION.

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

  MAUDE report 8398456 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ABOUT 16 SURGERIES ON HIS KNEE. NONE WERE FOR INFECTION THE LAST SURGERY WAS ABOUT A YEAR AGO IN (B)(6). THERE WAS A PF STEMS AND SLEEVES IN BOTH FEMUR AND TIBIA, AS WELL AS A 15MM THICK REV MBT TRAY. THE FEMUR WAS A TC3 AND A 2.5 17.5MM TC3 INSERT WAS IMPLANTED. THE PATIENT CAME TO SURGEON COMPLAINING OF PAIN, SWELLING AND INSTABILITY. THE XRAY SHOWS WELL FIXED IMPLANTS AND DURING SURGERY SURGEON RESECTED THE PATELLA AND REPLACED IT WITH A 38MM AND INCREASED THE INSERT TO A 22.5MM. HE DETERMINED THAT THE KNEE WAS MORE STABLE AND CLOSED. DOI: (1) ONE YEAR AGO; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain; Swelling

  MAUDE report 7337742 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7150759 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON DECIDED TO TAKE THE PATIENT TO SURGERY TO MOVE TO A SMALLER POLY AND REMOVE SCAR TISSUE.

  Patient problems: Pain

  MAUDE report 7099440 ↗