SIGMA 97-0460Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295250609), received between Sep 21, 2018 and Jan 16, 2025 — 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.

• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21168624 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED HER QUAD TENDON. SHE WAS BROUGHT TO OR FOR TENDON REPAIR AND POLY EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 17058416 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE MANIPULATION WAS PERFORMED FOR UNKNOWN REASON. DOI:(B)(6) 2022. DOE:- (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14013191 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE X-RAYS CONFIRMED THAT THERE WAS NO LOOSENING. THE SURGEON REPLACED A 4X8 CVD PLUS POLY WITH A 4X12.5 POLY TO INCREASE THE STABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11147804 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

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

  MAUDE report 10898431 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS ISSUE WITH RANGE OF MOTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2015; DOR: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 10858105 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY (B)(6) 2019 DURING KNEE REVISION SURGERY. THE SURGEON SAID THAT A FIXED FLEXION DEFORMITY WAS THE REASON FOR REVISION.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint

  MAUDE report 9369727 ↗
• InjurySep 21, 2018Adverse 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) 2017, DOR: (B)(6) 2018, UNKNOWN SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7897739 ↗