SIGMA 96-2355Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295242413), received between Jan 10, 2018 and Aug 4, 2026 — classified as 31 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was ligamentuos instability.DOI: (b)(6) 2024. DOR: (b)(6) 2026.Affected Side: Left.

  Patient problems: Joint Laxity

  MAUDE report 50133391 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25457474 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POLY EXCHANGES FOR INFECTION. NO HARM TO PATIENT. NO BROKEN INSTRUMENT. NO DELAYS. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 20912015 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. THERE WAS NO SURGICAL DELAY. 2. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18970481 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RANGE OF MOTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 18372679 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain; Wound Dehiscence

  MAUDE report 17058197 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2017; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17044206 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT WAS TAKEN OUT DURING REVISION SURGERY FOR INFECTION. ALL PIECES RETRIEVED. SURGEON DOES NOT WISH TO PROVIDE ADDITIONAL INFORMATION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16938005 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16585077 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SWELLING AND REDNESS IN KNEE AREA. SURGERY SCHEDULED (I AND D) WITH A POLY SWAP. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 16140817 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE? INFECTED - UNSTABLE SIGNASURE CAME BACK NEGATIVE FOR INFECTION PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE PLAN A- ATTUNE REVISION, PLAN B - ATTUNE HINGE PLAN C - TC3 FEMUR REVISION IF TIBIA WELL FIXED IN SITU - TC3FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR MBT TIBIA REVISION SIZE 3, WEDGE, STEM SIZE 4 20MM INSERT TC3 RP PATELLA 41MM 3 PEG.

  Patient problems: Joint Laxity

  MAUDE report 16017385 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLORATION RIGHT TC3 REVISION TKR FOR PAIN. PATIENT UNDERWENT REVISION TO TC3 TKR ON (B)(6) 2011. PRESENTED BACK TO SURGEON COMPLAINING OF PAIN. SURGEON UNSURE OF CAUSE OF PAIN, SCAN HAD SHOWN A 'HOTSPOT' AROUND THE PATELLA. PROCEDURE TODAY WAS REVISION OF PATELLA COMPONENT AND POLY EXCHANGE RIGHT TC3 REVISION TOTAL KNEE REPLACEMENT. SURGEON STATED HE THOUGHT THE PATELLA COMPONENT 'MAY HAVE BEEN LOOSE'. POLY WAS UPSIZED FROM 20MM TO 22.5MM.-- REVISION OF PATELLA COMPONENT AND POLY EXCHANGE RIGHT TC3 TKR, DOI: (B)(6), 2011. DOR: (B)(6), 2022. SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14315312 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY SWAP AND I&D DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13652067 ↗
• InjuryFeb 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED ON RIGHT KNEE SECONDARY TO SEVERAL DISLOCATIONS. SURGEON DISCOVERED THE TIBIAL INSERT WAS ROTATED 180 DEGREES POSTERIORLY. SURGEON NOTED LIGAMENTOUS DEFICIENCIES AND ELECTED TO CONVERT THE KNEE CONSTRUCT TO A HINGED FEMORAL COMPONENT. THE FEMORAL HINGE COMPONENT AND TIBIAL INSERT WERE EXCHANGED. THE INDEX FEMORAL SLEEVE AND STEM, THE TIBIAL CONSTRUCT, AND THE PATELLA WERE KEPT. SURGEON STATED HE DID NOT THINK THE COMPONENTS FAILED TO MEET EXPECTATIONS.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13559683 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. TIBIAL INSERT EXCHANGE ONLY. DATE OF IMPLANT: (B)(6) 2012, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE).

  Patient problems: Joint Contracture; Pain; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 12770083 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12397167 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12296662 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A WASHOUT WAS DONE AND A NEW INSERT OF THE SAME SIZE WAS REIMPLANTED. NO OTHER INFORMATION REGARDING THE PATIENT IS AVAILABLE. DOI: (B)(6) 2015, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11986298 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE ROTATION OF IMPLANTS. NO LOOSENING WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11804837 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11365705 ↗
• InjuryJan 7, 2021Adverse 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 DONE. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 11131485 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, EFFUSION, PAIN, DISCOMFORT, FEMORAL COMPONENT MIGRATION AND LOOSENING AT AN UNKNOWN INTERFACE, TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE, AND NO INGROWTH OF THE TIBIAL OR FEMORAL SLEEVES. THE UNKNOWN MANUFACTURER PATELLAR COMPONENT WAS RETAINED. ALL OTHER COMPONENTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Discomfort; Edema; No Code Available; Pain

  MAUDE report 10600347 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND DISLOCATION OF THE PATELLA. THE SURGEON DEBATED BETWEEN PUTTING A THICKER POLY OR REVISING THE FEMUR TO CHANGE THE JOINT LINE. THE SURGEON INCREASED THE POLY BY 2 SIZES AND WAS HAPPY WITH THE STABILITY AND TRACKING OF THE PATELLA WITH THE THICKER INSERT. ORIGINAL IMPLANTATION DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020.

  Patient problems: No Code Available; Pain

  MAUDE report 10296758 ↗
• InjuryJun 29, 2020Malposition of Device; Malposition of Device

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF BOTH FEMORAL AND TIBIAL COMPONENTS : ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Bone Fracture(s); Injury; Muscular Rigidity; No Code Available; Pain; Swelling; Synovitis

  MAUDE report 10207362 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN UNSTABLE KNEE. THE SURGEON REMOVED THE 4X20 TC3 INSERT AND REPLACED WITH A 4X25 MM POLY TO HELP CORRECT PATIENT INSTABILITY AND GIVE THEM BETTER RANGE OF MOTION.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9369422 ↗