SIGMA 97-0441Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295250494), received between Oct 6, 2021 and Aug 7, 2026 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  (b)(6) first report of retrievals for Statement of Work 10 for Q2 of 2026. (b)(6) is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to pain. The non-articular surface of the fixed-bearing polyethylene tibial insert shows minor yellowing.

  Patient problems: Pain

  MAUDE report 50180087 ↗
• InjuryMay 2, 2025Adverse 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 STIFFNESS AND LACK OF MOTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 21950452 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND WASHED OUT WITH NEW POLY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20212218 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT¿S KNEE HAD BECOME SLIGHTLY LAX AND SURGEON ELECTED TO INCREASE INSERT THICKNESS TO STABILIZE THE KNEE. IT WAS UNKNOWN WHEN, WHERE, OR WHICH SURGEON PUT THIS KNEE IN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19133496 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SYNOVECTOMY AND POLY EXCHANGE WAS DONE. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE : RIGHT KNEE

  Patient problems: Insufficient Information

  MAUDE report 18443439 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT AND POLY EXCHANGE PERFORMED FOR INFECTION. DOI: UNKNOWN AND DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17815957 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY AND THIS HAD PAIN WHEN THE ORIGINAL CONSTRUCT WAS PUT IN. THE SURGEON TOOK IT ALL OUT, AND PUT IN A COMPETITOR REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16233203 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. POLY EXCHANGE WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12583601 ↗