SIGMA 86-6499Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295217206), received between Mar 14, 2022 and Jan 30, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 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.

• MalfunctionJan 30, 2024Wrong Label; Wrong Label

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO, IT WAS DISCOVERED DURING INVENTORY MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606232 ↗
• InjurySep 30, 2022Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  SURGEON REPORTED TO BFARM: "AFTER REVISION PROSTHESIS OF (B)(6) 2021, THE PATIENT MADE A WRONG MOVEMENT IN THE SWIMMING POOL AND HAD PAIN AFTERWARDS. RADIOLOGICALLY, THERE WAS A FRACTURE OF THE CONNECTION BETWEEN THE STEM AND THE SLEEVE WITH A NON-CONSOLIDATED DISTAL FEMUR FRACTURE ON THE RIGHT." DOI: (B)(6) 2021. DOR: (B)(6) 2022. RIGHT SIDE.

  Patient problems: Bone Fracture(s); Discomfort; Fatigue; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

  MAUDE report 15519157 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. THERE WAS ALSO LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13757190 ↗