SIGMA 96-2335Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295242161), received between Apr 23, 2018 and Nov 7, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO PATELLA WEAR AND POLY EXCHANGE. SURGEON WASN¿T SURE WHEN THE PREVIOUS SURGERY WAS DONE OR WHERE IT WAS DONE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR:(B)(6) 2023; AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 18085785 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882781 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXTENSOR MECHANISM DEFECT AND PREVIOUS INFECTION. SHE WAS LEFT WITH SOME LAXITY AND NEEDED A THICKER POLY AFTER THE SYNOVECTOMY AND REPAIR. NO LOOSENING OF COMPONENTS REPORTED. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11916362 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AT THE END OF STEM AND IN THE TIBIA. REMOVED POLY TRAY AND STEM. IMPLANTED SHORT CEMENTED STEM, NEW TRAY AND POLY. DOI: (B)(6) 2018. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11311469 ↗
• InjuryFeb 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. POLY SWAP PERFORMED. NO LOOSENING AND DELAY TO SURGERY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 11289892 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020 UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10485427 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9857090 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FALL AND TORE HER EXTENSOR MECHANISM. AFTER FALLING, THE SURGEON REPAIRED THE EXTENSOR AND WENT DOWN A POLY SIZE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9370827 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7450245 ↗