SIGMA 97-0452Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295250562), received between Sep 26, 2019 and May 7, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. POLY SWAP. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25116337 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23719609 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLY SWAP WAS PERFORMED FOR INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22009012 ↗
• InjuryDec 2, 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 INFECTION AND UNDERWENT WASHOUT WITH A NEW POLY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20820461 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 19115729 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POLY EXCHANGE DUE TO INFECTION. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16854695 ↗
• InjuryApr 17, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON HAD NOTED INSTABILITY AND POSSIBLE POLY WEAR. A 3X12.5 POLY WAS REMOVED. A TRIAL WAS PLACED IN OF SIMILAR SIZE. ENDED UP UPSIZING INSERT TO A 15. PUT THE KNEE THROUGH A ROM AND LIKE THE RESULTS. DOI: UNKNOWN. DOR: MARCH 30,2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16751542 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY EXCHANGE DUE TO INFECTION. NO DELAYS TO SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11974148 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 06 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2013, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2013, THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION DUE TO STIFFNESS. THE SURGEON INDICATED PALPABLE LYSIS OF ADHESIONS WERE FELT. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY WITH RESECTION OF SCAR TISSUE. DUE TO PAIN. THE SURGEON REPORTED THE SCAR TISSUE WAS REMOVED, AND NO INTEROPERATIVE COMPLICATIONS. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING AND ARTHROFIBROSIS. THE SURGEON NOTED THE FEMORAL COMPONENT WAS NOT GROSSLY LOOSE BUT REMOVED VERY EASILY, AND THE TIBIAL COMPONENT DIS-IMPACTED RATHER EASILY. THE SURGEON DID NOT REPORT WHICH INTERFACES HE FOUND LOOSENING. THE PATELLA WAS REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. UN

  Patient problems: Adhesion(s); Fibrosis; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9125651 ↗