SIGMA 96-2323Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295242062), received between Apr 23, 2018 and Mar 25, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN THAT IF THERE WAS ANY LOOSENING. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18970819 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14104029 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: 10/07/2020, DOR: 10/19/2021, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719486 ↗
• InjuryJul 6, 2021Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO EXPERIENCED SIGNIFICANT DECREASE IN ROM. PATELLA AND POLY EXCHANGE DONE. A SIGNIFICANT AMOUNT OF HETEROTROPHIC BONE FORMATION WAS FOUND DURING THE REVISION AND REMOVAL OF IMPLANT. MINIMAL WEAR WAS NOTED ON THE POLYETHYLENE COMPONENTS. DOI: (B)(6) 2016, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 12120865 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY DUE TO FALL. DOI: (B)(6) 2015; DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9577748 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 DOCTORS NOTES INDICATE THAT THE PATIENT HAS A DISPLACED PATELLAR FRACTURE WITH LOOSENED PATELLAR COMPONENT, PAIN, AND INSTABILITY. THE REVISION NOTES WERE NOT PROVIDED AT THE TIME OF THIS REVIEW, BUT A STICKER SHEET SHOWS THAT THE PATIENT WAS RE-IMPLANTED WITH A TIBIAL INSERT, COMPETITOR ALL POLY PATELLA, AND COMPETITOR CEMENT. NO OTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 9207793 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY SWAP FOR AN INFECTION OF THE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8387590 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN. INCREASED THICKNESS OF TIBIAL INSERT. DOI: (B)(6) 2017 DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7450612 ↗