S-ROM NOILES 62-1635Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295179085), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2017 WHERE AN S ROM HINGE KNEE WAS UTILIZED. PATIENT INITIALLY HAS DONE VERY WELL UNDERTAKING CLEANING WORK AND KNEELING ON HER KNEE. PATIENT WAS PRESENTED WITH A PAINFUL KNEE ON (B)(6). X RAYS INDICATE THAT THE PATELLA COMPONENT APPEARS TO HAVE COME LOOSE. A DECISION WAS MADE TO OPEN THE KNEE. ON OPENING THE KNEE, THE PATELLA COMPONENT HAD COME LOOSE, WITH 2X OF THE 3 PEGS HAVING BROKEN OFF, THE THIRD PEG WAS STILL ATTACHED TO THE UNDERSIDE OF THE PATELLA. THE PATELLA BONE WAS CLEANED AND A SMALL AMOUNT RESECTED TO CREATE HEALTHY BONE AND A PFC OVAL DOME IMPLANTED. THE FEMORAL COMPONENT, TIBIAL COMPONENT AND THE INSERT APPEARED TO BE IN GOOD CONDITION AND WELL FIXED, AND A DECISION WAS MADE TO LEAVE THESE IN SITU.

  Patient problems: Pain

  MAUDE report 11163270 ↗