S-ROM NOILES 62-3685Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295179535), received between Jul 6, 2017 and Jul 25, 2024 — classified as 2 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 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.

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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PROXIMAL TIBIAL REPLACEMENT SURGERY DUE TO BONE CANCER 14 YEARS AGO. SURGEON DID A POLY SWAP, HINGE PIN, AND BUMPER EXCHANGE IN 2018. SURGEON PERFORMED ANOTHER POLY SWAP HINGE PIN AND BUMPER EXCHANGE AGAIN (B)(6) 2024 DUE TO INSTABILITY OF THE KNEE. IT WAS THOUGHT THAT SOMETHING BECAME LOOSE IN THE KNEE. UPON INSPECTION OF THE INSERT IT LOOKED AS IF THE METAL POST IN THE INSERT WAS SLIGHTLY TOGGLING BUT WAS INCONCLUSIVE IF THE BEARING HAD BROKEN WITHIN THE INSERT. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19827870 ↗
• InjuryJul 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6688904 ↗