SIGMA 96-2342Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295242222), received between Jul 20, 2017 and Jun 28, 2024 — classified as 16 injuries, 1 malfunction.

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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A WASH OUT OF IMPLANT FOR POSSIBLE INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19633361 ↗
• InjuryNov 29, 2023Naturally Worn; Naturally Worn

  KNEE REPLACEMENT TC3 SURGERY 8 YEARS AGO (2015) WITH STEM AND SLEEVES BOTH TIBIA AND FEMUR. ADAPTER AND BOLT IS BROKEN. FEMUR HAD NO CONTACT. SLEEVE VERY WELL FIXATED. CLINICAL OUTCOME EXPERIENCED BY THE PATIENT, EXTRACTION OF THE IMPLANTS, SURGERY WITH SPACER AND PLANNED FOR LPS REVISION. ADDITIONAL EVENT INFORMATION: IT WAS FOUND DURING THE VISUAL EXAMINATION PERFORMED ON 22NOV2023 THAT THE TIBIAL INSERT IS DAMAGED/WORN.

  Patient problems: Insufficient Information

  MAUDE report 18226963 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. SURGEON PUT LARGER POLY IN KNEE. KNEE IS STABLE. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 17797599 ↗
• MalfunctionJun 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE TC3 TOTAL KNEE PROSTHESIS HAS BEEN "UNBUNDLED" (SEE PHOTOS IN ATTACHMENT). IT WAS DECIDED TO POSE A NOILES, TAKING INTO ACCOUNT THE NUMBER OF INTERVENTIONS ALREADY UNDERWENT BY THE PATIENT WITHOUT CHANGING THE TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105824 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED KNEE. I&D AND POLY SWAP WERE PERFORMED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2018, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16303414 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED LOOSE TC3 RP WITH MID FLEX LAXITY AT THE BONE TO CEMENT INTERFACE. FEMUR WAS REMOVED BUT QUESTIONABLE WHETHER LOOSE OR NOT - MID FLEX LAXITY MAIN ISSUE - RE IMPLANT TC3 RP WITH 8 MM DISTAL AUGMENTS - ADDRESSED MF LAXITY - BALANCED AND PATELLA TRACKED WELL. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16094104 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14142323 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY DUE TO FALL AND A BONE SCAN WAS ORDERED IT WAS DETERMINED THAT THE FEMORAL COMPONENT WAS LOOSED AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. ALL THE COMPONENTS WERE REMOVED EXCEPT THE PATELLA. NEW REVISION COMPONENTS WERE IMPLANTED AND THE HAS A FULL RANGE OF MOTION FROM EXTENSION TO FLEXION. NO SURGICAL DELAY. DOI : (B)(6) 2018 DOR : (B)(6) 2021 RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12719718 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL RIGHT TOTAL KNEE WITH CREPITANS, ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010 (COMPETITOR KNEE SYSTEM). DATE OF REVISION #1: (B)(6) 2010 (REVISION OF COMPETITOR FEMUR, TIBIAL TRAY, INSERT - COMPETITOR PATELLA RETAINED). DATE OF EVENT (ONSET): (B)(6) 2013 (RIGHT KNEE). TREATMENT: SURGICAL ARTHROTOMY WITH EXCISION OF SCAR TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12363729 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MCL RUPTURE. REVISED FEMORAL COMPONENT AND TIBIAL POLY TO A SROM HINGE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10291858 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PAIN WITH SUSPECTED INFECTION. IMPLANT DATE: (B)(6) 2017.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; No Code Available; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 9865816 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE DUE TO PAIN AND INSTABILITY. DOI: (B)(6) 2016; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9311898 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8833512 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. NOTE IN EXPLANTED PRODUCTS LEFT DISTAL AUGMENTS (2) SHARE THE SAME LOT NUMBER. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8784869 ↗
• InjuryAug 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POLY EXCHANGE WAS DONE DUE TO INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7757852 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL DATABASE NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DOI OF FEMORAL COMPONENT AND ADAPTORS: (B)(6) 2015. DOI OF TIBIAL TRAY, INSERT, AND SLEEVE: (B)(6) 2016 . DOR: (B)(6) 2018; (LEFT, KNEE). PLEASE NOTE, PATIENT HAS BEEN REVISED 2 TIMES PREVIOUSLY. THESE REVISIONS ARE CAPTURED ON (B)(4).

  Patient problems: Pain

  MAUDE report 7751522 ↗
• InjuryJul 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6730318 ↗