SIGMA 1024-53-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295002550), received between Jan 20, 2020 and Mar 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT REPORTS THAT ON (B)(6) 2025 HE UNDERWENT A 1.5T LIVER MRI. THE PATIENT HAS A LEFT KNEE PROSTHESIS IMPLANTED ON (B)(6) 2025. DURING THE EXAMINATION, THE PATIENT REPORTS INITIALLY FEELING WARMTH, WHICH PROGRESSIVELY INTENSIFIED, REACHING ALMOST UNBEARABLE HEAT IN THE LOWER PART OF THE PATELLA OF THE LEFT KNEE (WHERE THE PROSTHESIS IS IMPLANTED). HE DOES NOT RECALL WHETHER THERE WAS REDNESS AT THE LEVEL OF THE KNEE. AFTER THE EXAMINATION, THE PATIENT CONTINUED TO EXPERIENCE SEVERE PAIN, UNTIL ON (B)(6) 2025 IT WAS DECIDED TO REPLACE THE PROSTHESIS WITH A NEW ONE (THE SURGERY WAS PERFORMED AT AN INSTITUTE DIFFERENT FROM HOSPITAL, THEREFORE WE DO NOT HAVE FURTHER DETAILS). THE DEVICE CARDS WERE REQUESTED (ATTACHED TO THE REPORT), AND BOTH ARE INDICATED BY THE COMPANY AS MRI SAFE. THE PROSTHESIS CONSISTS OF 3 COMPONENTS, ALL INDICATED ON THE ATTACHED LABELS.

  Patient problems: Inflammation; Pain

  MAUDE report 24484115 ↗
• MalfunctionJun 20, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE INSERT DID NOT MATCH THE CLASP AND COULDN'T BE CLAMPED ONTO THE TIBIAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164822 ↗
• MalfunctionJan 20, 2020Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A UNICOMPARTMENTAL KNEE REPLACEMENT ON THE LEFT MEDIAL COMPARTMENT ON THE PATIENT. NORMAL PROTOCOL WAS TAKEN AS FAR AS INSTRUMENTS AND IMPLANTS AT THE HOSPITAL PRIOR TO THE CASE. FIRST ISSUE WAS WITH THE "ANTERIOR CHISEL" THROUGH THE ANTERIOR CHAMFER OF THE SIZE 2 CUTTING BLOCK. THE CHISEL (202485000 LOT PG0608) SPLIT IN HALF INSIDE THE CUTTING BLOCK. THE BLOCK WAS REMOVED FROM THE DISTAL FEMUR, THE BROKEN CHISEL WAS THEN REMOVED FROM THE CUTTING BLOCK. THE CUTTING BLOCK WAS PLACED BACK ON THE DISTAL FEMUR AND THE LUG DRILL WAS ALLOWED TO PASS THROUGH THE ANTERIOR CHAMFER. THIS PROBLEM DID EXTEND THE TIME OF THE OPERATION. THE REST OF THE OPERATION WENT SMOOTHLY UNTIL INSERTION OF THE FINAL POLY IMPLANT. THE SURGEON HAS A VERY DETAILED AND THOROUGH DEBRIDEMENT OF THE IMPLANTS BEFORE HE PLACES HIS FINAL INSERT COMPONENT ON ALL OF HIS TOTAL AND UNICOMPARTMENT KNEES. THERE WAS NO CEMENT ON THE TRAY, NO SOFT TISSUE POSTERIOR AND THERE WAS NO SOFT TISSUE COVERING THE TIBIAL COMPONENT TO PREVENT INSERTION OF THE POLY IN TO THE TIBIAL COMPONENT. THE DESIRED POLY THICKNESS WAS OPENED AND MATCHED THE IMPLANTED LM SIZE 3 TIBIAL COMPONENT. THE I

  Patient problems: Not Applicable

  MAUDE report 9607952 ↗