SIGMA 1024-52-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295002413), received between Nov 5, 2018 and Jul 25, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINANT REPORTED HE HAD ONE PARTIAL KNEE SURGERY AND A SECOND ONE THAT WAS AN EMERGENCY REVISION OF THE FIRST SURGERY. COMPLAINANT STATED ONE OF THE KNEE RECONSTRUCTIONS FAILED WHILE HE WAS CLIMBING STAIRS. COMPLAINANT STATED THE POLYURETHANE CAME OUT OF PLACE. COMPLAINANT STATED HE HAS A PARTIAL KNEE REPLACEMENT CONDUCTED TO SAVE THE KNEE REPLACEMENT. WHEN THE KNEE REPLACEMENT FAILED A SECOND TIME, HIS DOCTOR RECOMMENDED HE OBTAIN A SECOND OPINION OR OBTAIN ANOTHER SECOND FULL KNEE REPLACEMENT. COMPLAINANT STATED HE OBTAINED A SECOND OPINION AND WAS INFORMED THAT THE SECOND DOCTOR WOULD NOT PERFORM A KNEE REPLACEMENT SURGERY AFTER ANOTHER DOCTOR HAD PREVIOUSLY CONDUCTED SURGERY THE FIRST TIME. SECOND DOCTOR INFORMED THE COMPLAINANT HE WOULD PERFORM THE FULL KNEE REPLACEMENT SURGERY WITH THE ASSISTANCE BY FIRST DOCTOR. THE COMPLAINANT STATED ONE OF THE KNEE RECONSTRUCTIONS FAILED IN 2020. THE PATIENT IS STATUS-POST-RIGHT PARTIAL KNEE REPLACEMENT REVISION PERFORMED ON 2019 AND A RIGHT PARTIAL KNEE REPLACEMENT PERFORMED ON 2018. DOI- UNKNOWN. DOR- UNKNOWN. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17390340 ↗
• MalfunctionDec 13, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT KNEE MEDIAL SIDE RM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987114 ↗
• InjuryApr 6, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELT THAT THE PARTIAL KNEE REPLACEMENT FAILED HIM BY COMING OUT OF PLACE AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019. ORIGINAL PROCEDURE WAS ON (B)(6) 2018. DOI: (B)(6) 2018; DOR: (B)(6) 2019; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information; Joint Laxity; No Code Available; Pain

  MAUDE report 9929379 ↗
• MalfunctionNov 29, 2018Fitting Problem; Fitting Problem

  ONCE IMPLANTED THE TIBIAL COMPONENT, THE SURGEON TRIED TO PLACE TO INSERT BUT BOTH DIDN'T ASSEMBLY TO THE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116166 ↗
• InjuryNov 5, 2018Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO FRACTURE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 8039163 ↗