SIGMA 96-2343Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295242239), received between Oct 19, 2017 and Jun 23, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP AFTER QUAD TEAR. SURGEON DECIDED TO UP SIZE THE POLY. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25599226 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24800053 ↗
• InjuryJul 24, 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 INFECTION AND POLY EXCHANGE OF KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22588479 ↗
• InjuryApr 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 DUE TO PAINFUL TKA. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain

  MAUDE report 19082434 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY EXCHANGE FOR LIGAMENT LAXITY AFTER FALL AND QUAD TENDON RUPTURE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023; DOR- (B)(6) 2023; AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Fall; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17824990 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD DEVELOPED POSTERIOR OSTEOPHYTES AND WAS DISCLOSING BY JUMPING THE POST WHILE LEVERING AGAINST/OVER THE POSTERIOR OSTEOPHYTES. POLY SWAP WAS PERFORMED. PATIENT REPORTS HAVING THIS SURGERY PERFORMED 15 YEARS AGO. NO RECORDS HAVE BEEN FOUND. DOI: 15 YEARS AGO. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 15895528 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "(B)(6) LEFT A VOICEMAIL FOR ONE OF MY TEAM MEMBER. HE DIDN¿T LEAVE ANY INFORMATION EXCEPT THAT HE HAD A KNEE REPLACEMENT TWICE. HE EXPECTS A CALL BACK. COULD YOUR TEAM REACH OUT TO HIM?"

  Patient problems: Adhesion(s); Inflammation; Joint Laxity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 15885749 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON INDICATED THAT THE PATIENT KNEE WAS INFECTED. DOI: (B)(6) 2018 DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14988424 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION TKA AFTER AN INFECTION WITH A TC3 IMPLANTS PLACED ON (B)(6) 2020. SHE WAS RETURNED TO SURGERY TODAY DUE TO A REPEAT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. ADDITIONAL PART USED AND REMOVED, NOT RETURNED 960784/J38U33 960861/HK5168 962343/HU0956. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043561 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. NO DELAY IN SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13017758 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEFT TOTAL SIGMA KNEE THAT IS INFECTED. IT IS UNKNOWN WHEN THE KNEE WAS DONE. THE SURGEON DID A WASHOUT WITH TIBIAL INSERT EXCHANGE. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12295125 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RIGHT KNEE WAS REVISED TO ADDRESS PAIN. POLY EXCHANGED WERE PERFORMED. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12036864 ↗
• InjuryJun 16, 2021Unintended Movement; Unintended Movement

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON SCHEDULED SURGERY TO INSPECT COMPONENTS AND REPLACE POLY WITH A THICKER MODEL. ALL COMPONENTS PASSED INSPECTION AND A THICKER POLY INSERTED FOR BETTER STABILIZATION. DOI: (B)(6) 2017 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12011013 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. DOCTOR PERFORMED I&D ALONG WITH POLY SWAP. PUT ANOTHER 3X15 POLY IN. ALL OTHER IMPLANTS WERE LEFT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10666567 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. NEW INSERT IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10593965 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY UNICOMPARTMENTAL SURGERY. THIS WAS REVISED TO A PFC TC3 REVISION ON (B)(6) 2014 (PLEASE NOTE THAT I DO NOT BELIEVE THAT THE UNI KNEE WAS A DEPUY PRODUCT BUT A COMPLAINT SEARCH MAY ESTABLISH THIS). FOLLOWING THE PFC TC3 REVISION, THE PATIENT HAS COMPLAINED THAT THE KNEE HAS NEVER FELT GOOD. RECENT X RAYS SHOW EXTENSIVE HETEROTOPIC OSSIFICATION, ESPECIALLY AROUND THE LATERAL EDGES OF THE TIBIAL COMPONENT. A DECISION WAS MADE TO OPEN THE KNEE ON (B)(6) 2020 TO REMOVE THE EXTRA BONE. AS EXPECTED THERE WAS FAIRLY EXTENSIVE BONE AROUND THE LATERAL EDGES ON THE COMPONENT WHICH APPEARED TO BE IMPINGING ON BOTH THE SOFT TISSUE AND THE MOBILE BEARING INSERT. THIS BONE WAS REMOVED AND A NEW 15MM TC3 RP BEARING INSERTED (SAME BEARING THAT WAS REMOVED TO GAIN EXPOSURE.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 10285501 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. A POLY SWAP WAS DONE AND THE PATELLA WAS RECUT AND UPSIZED TO A SIZE 38. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10185841 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION: SOFT TISSUE UNSTABLE - MEDICAL COLLATERAL LIGAMENT. (B)(6) 2020. REMOVED TCS FEMUR AND TC3 RP CLEANED UP AND PREPARED AND S SROM HINGE WAS INSERTED.

  Patient problems: No Code Available; Pain

  MAUDE report 9707420 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FELT AS THOUGH THE PATIENT NEEDED A THICKER LINER TO HELP ALLEVIATE PAIN. DOI: (B)(6) 2015; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9136659 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD TO REVISE AN SIGMA TC3 AND MBT REVISION TIBIA DUE TO PATIENT DISCOMFORT AND INSTABILITY. SURGEON REMOVED ALL EXISTING IMPLANTS AND PERFORMED REVISION WITHOUT ANY INCIDENT.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8623577 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FOR LEFT KNEE INSTABILITY. DOI: UNKNOWN; DOR #1: (B)(6) 2016; DOR: (B)(6) 2019; (LEFT KNEE). TIBIAL INSERT WAS REVISED.

  Patient problems: No Code Available; Pain

  MAUDE report 8608209 ↗
• InjuryMay 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7529131 ↗
• InjuryOct 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6960982 ↗