SIGMA 96-2357Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295242444), received between Aug 29, 2018 and Feb 11, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON WAS CONCERNED ABOUT AN INFECTION SO SURGEON PERFORMED A WASHOUT AND POLY SWAP. DOI: (B)(6) 2021. DOR: (B)(6) 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24317286 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, POLY SWAP AND I&D. DOI: (B)(6) 2025 DOR: JUN 12, 2025 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22372340 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED TO HINGE DUE TO LAXITY IN THE TISSUES. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21873171 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE OF MEDIAL AND LATERAL FEMORAL CONDLYLES: ABNORMAL RADIOGRAPHIC EVALUATION - LIKELY FEMORAL COMPONENT LOOSENING (UNCONFIRMED), WITH FRACTURE OF THE MEDIAL AND LATERAL CONDYLES, AND INSTABILITY EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION: (B)(6) 2017 (ALL COMPONENTS) DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION OF THE FEMORAL AND INSERT COMPONENTS OCCURRED ON (B)(6) 2021.

  Patient problems: Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12415376 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE. IT IS NOTED THE PATIENT ALSO HAD A LEFT KNEE ARTHROPLASTY OF UNKNOWN MANUFACTURER PRODUCTS PLACED IN 2014 WITH NO ISSUES.

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

  MAUDE report 11812733 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, POLY SWAP WAS DONE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10663611 ↗
• InjuryJul 20, 2020Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE AND NEEDS TO CONVERT TO HINGE. THE SALES REP DO NOT HAVE THE EXACT DATE OF SURGERY AND ENTERED (B)(6) 2011 INSTEAD. THE SURGEON STATED THAT THE PART OF THE PS POST ON THE TC3 POLY WAS BROKEN OFF. SURGEON KNOCKED FEMORAL COMPONENT OFF, LEAVING THE SLEEVE AND STEM IN THE FEMUR. THE TIBIAL COMPONENTS ALSO STAYED IN. NO SURGICAL DELAY. DOI: (B)(6) 2011, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10298884 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BLEW OUT HIS QUAD TENDON AND HAD TO HAVE ALLOGRAFT TO REPAIR IT, WENT UP A POLY SIZE TO MAKE THE KNEE STABLE AGAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9918022 ↗
• InjuryAug 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I AND D AND POLY SWAP WAS PERFORMED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7828603 ↗