S-ROM NOILES 62-3805Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295179542), received between Aug 14, 2018 and Apr 23, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE. IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24966528 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ABOVE THE KNEE AMPUTATION RELATED TO WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOE: (B)(6) 2011; DOI: (B)(6) 2011; DATE OF AMPUTATION: (B)(6) 2011; (RIGHT, KNEE).

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7780897 ↗