SIGMA 96-2354Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295242390), received between Jul 21, 2017 and Jun 22, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BEING REVISED WITH A POLY SWAP FOR GROSS INSTABILITY. SURGEON REMOVED SZ 4 X 5MM TC3 POLY AND REPLACED WITH A 25MM. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25575923 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PRIMARY REVISION OUT OF STATE MANY YEARS AGO. THE REVISION OCCURRED DUE TO INSTABILITY - ALL METAL HARDWARE WAS WELL FIXED AND DID NOT NEED REVISED - POLY SWAP WITH INCREASE IN POLY THICKNESS WAS DETERMINED TO ADDRESS THE PRIOR INSTABILITY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24589045 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21572936 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASHOUT FOR INFECTION. SIGMA TC3 SIZE 4 ,12.5 INSERT REMOVED AND SIZE 4 TC3 SIZE 4 17.5 WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 19020113 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18182242 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CHIEF COMPLAINT WAS PAIN. SURGEON TOLD THE PATIENT HE HAD A CHRONIC INFECTION IN THIS KNEE. DOCTOR REMOVED THE INSERT TO IMPROVE EXPOSURE, THEN PROCEEDED TO PERFORM AN I&D, REMOVING ALL BAD TISSUE. AFTER THE WASHOUT AND DEBRIS WAS REMOVED, SURGEON EXAMINED THE OTHER COMPONENTS AND THEY APPEARED TO BE WELL POSITIONED AND SOLIDLY FIXED. SURGEON REPLACED THE SAME SIZE AND THICKNESS INSERT WITH A NEW ONE. THE PATIENT WAS CLOSED IN THE USUAL FASHION. DOI: (B)(6) 2007 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17869289 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2023, DUE TO INSTABILITY. SURGICAL DELAY IS UNKNOWN. THIS REPORT IS FOR A TC3 RP TIBIAL INSERT S4,17.5 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 17299097 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF A KNEE WAS (B)(6) 2018 AND A SUBSEQUENT POLY EXCHANGE WAS PERFORMED ON (B)(6) 2021. PATIENT PRESENTS WITH PAIN AND INSTABILITY. TAKEN TO OR TO TRAY TO ADDRESS CAUSE AS XRAYS DO NOT SHOW CLEAR ISSUES. INSERT, FEMORAL COMPONENT, FEM ADAPTER AND BOLT WERE REMOVED BUT SLEEVE AND STEM WERE LEFT AS THEY WERE WELL FIXED. AN LPS ADAPTER AND DISTAL FEMORAL COMPONENT WERE PLACED ALONG WITH HINGED INSERT UNEVENTFULLY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17208027 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS BEEN BEING TREATED FOR CHRONIC INFECTION IN GJ. CAME FOR FURTHER TREATMENT. I&D WITH POLY EXCHANGE SCHEDULED. TIBIA WAS LOOSE UPON INFRA OPERATIVE EVALUATION ( SIGMA MBT W A SLEEVE AND PRESS FIT STEM - NOT PRODUCT NUMBERS OR LOT NUMBERS). THE TIBIA DISENGAGED FROM THE SLEEVE BUT THE SLEEVE DID NOT MOVE. IT WAS DECIDED TO CLEAN UP THE EXPOSED TIBIA INSTU AND REINSERT IT WITH CEMENT ON THE UNDERSURFACE. THIS WAS DUE TO THE POOR HEALTH AND AGE OF THE PATIENT. SERIAL I&DS MAY BE PERFORMED. UNKNOWN DATE OR LOCATION OF INSERTION OF THE COMPONENTS. THE TRAY CAME LOOSE WHEN THE SURGEON IMPACTED IT FROM THE FRONT EDGE. CEMENT REMAINED ON BOTH THE IMPLANT AND ON THE BONE. THE SLEEVE DID NOT MOVE AT ALL. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12353147 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IS PART OF A SERIAL I&D WITH A POLY EXCHANGE FROM THE CASE ON (B)(6) 2012 WITH THE FOLLOWING COMMENTS LISTED THERE: PATIENT HAS BEEN BEING TREATED FOR CHRONIC INFECTION IN GJ. CAME FOR FURTHER TREATMENT. I&D WITH POLY EXCHANGE SCHEDULED. TIBIA WAS LOOSE UPON INTRA-OPERATIVE EVALUATION ( SIGMA MBT W A SLEEVE AND PRESS FIT STEM - NOT PRODUCT NUMBERS OR LOT NUMBERS). THE TIBIA DISENGAGED FROM THE SLEEVE BUT THE SLEEVE DID NOT MOVE. IT WAS DECIDED TO CLEAN UP THE EXPOSED TIBIA INSTU AND REINSERT IT WITH CEMENT ON THE UNDERSURFACE. THIS WAS DUE TO THE POOR HEALTH AND AGE OF THE PATIENT. SERIAL I&DS MAY BE PERFORMED. UNKNOWN DATE OR LOCATION OF INSERTION OF THE COMPONENTS. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12342436 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2027; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11693312 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Muscle/Tendon Damage

  MAUDE report 11682081 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO END OF STEM PAIN. THE SURGEON REVISED THE ENTIRE CONSTRUCT TO A COMPETITIVE COMPANY. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11462611 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TIGHT IN EXTENSION. SURGEON WAS DROPPING DOWN IN POLY SIZE. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 10787617 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10315649 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10283578 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A WASHOUT AND A POLY SWAP WERE PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10251729 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT IS SEPTIC. I/D AND IRRIGATION WITH POLY SWAP WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10017389 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9806205 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE TIBIAL AUGMENT WAS NOT COMPLETELY SCREW DOWN AND IT CREATED SOME METALLOSIS. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9446212 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS: A PAINFUL AND SWOLLEN KNEE PATIENT THAT HAD AN I&D WASH OUT WITH POLY EXCHANGE OF THERE INSERT.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 7908383 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGED. DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7596485 ↗
• InjuryJan 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INFECTION. NEEDED TO BE WASH-OUT. DOI: UNKNOWN. (B)(6) 2018. LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7227690 ↗
• InjuryNov 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO REPORTED THAT POLY SWAP AND I&D WERE PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7065917 ↗
• InjuryNov 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 6992843 ↗