S-ROM NOILES 62-3401LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295179467), received between Aug 3, 2020 and Jun 29, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (3 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED WITH MRSA. PIN AND INSERT WERE REMOVED. WASHED OUT. NEW INSERT AND REPLACEMENT PIN IMPLANTED. DOI: (B)(6), 2024 DOR: (B)(6), 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25655252 ↗
• InjurySep 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A KNEE REVISION. WE HAVE REVISED A NOILES FEMUR WHICH APPEARS TO HAVE SNAPPED AT THE BASE OF THE FEMORAL COMPONENT AND THE SLEEVE THE PROCEDURE WAS DONE 9 YEARS AGO. IT IS THE 3RD TIME THIS PATIENT HAS BEEN REVISED.

  Patient problems: Insufficient Information

  MAUDE report 23051345 ↗
• InjuryJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO BREAKAGE OF S-ROM. DOI: ON (B)(6) 2020. DOE: ON (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 19709242 ↗
• InjuryDec 7, 2023Fracture; Fracture

  A: DATE: (B)(6) 2020 FOR IMPLANTATION OF THE LATER FRACTURED IMPLANT. EVENT OF FRACTURE IS LIKELY (B)(6) 2023 WHERE THE PATIENT EXPERIENCED PAIN AND IMPAIRED MOVEMENT WITHOUT TRAUMA B. YES. TOTAL FRACTURE OF THE IMPLANT WITH INABILITY TO MOBILISE AND NEED FOR SIGNIFICANT SECONDARY SURGERY. C. YES. THE PATIENT WAS REVISED (B)(6) 2023. HAS THE REVISION SURGERY OCCURED? AS PER A-10179127 IT WAS PLANNED FOR 24-NOV.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 18281927 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR AN INFECTED LEFT HINGE KNEE. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED. THERE WERE NO SURGICAL DELAYS, DEFICIENCIES OR BROKEN INSTRUMENTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17135073 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HINGED KNEE PLACED STATUS POST KNEE SPACER ON (B)(6) 2022. PATIENT CAME BACK TO HOSPITAL WITH A WARM RED KNEE. SURGEON BELIEVED INFECTION WAS STILL PRESENT AND ALL COMPONENTS WERE REMOVED AND NEW SPACER WAS FASHIONED UTILIZING LPS COMPONENTS AS THE MCL WAS FOUND TO BE INCOMPETENT AT THE TIME OF SURGERY ON (B)(6) 2022. A DUAL SET WAS UTILIZED AND ANTIBIOTIC BEADS WERE PLACED ALONG WITH HIGH DOES ANTIBIOTIC CEMENT. CEMENT IS DEPUY 2 WITH GENT BUT LOT IS UNAVAILABLE AS IT IS HOSPITAL OWNED INVENTORY. DUE TO SHORT DURATION OF IMPLANTATION AND SUSPECTED INFECTION, NEITHER SLEEVE WAS INGROWN AT TIME OF REMOVAL. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14773882 ↗
• InjuryMar 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, SLEEVE, STEM, AND POLY WERE REMOVED AND REPLACED WITH A DISTAL FEMUR. UNKNOWN CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11554244 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTEDLY UNDERWENT QUAD TENDON DAMAGE REPAIR. INSERT WAS REPLACED. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11506679 ↗
• InjuryAug 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESSED LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT IS HAVING PAIN AND DISCOMFORT IN THE KNEE SURGEON NOTICE THAT THE FEMUR MAY HAVE BEEN LOOSE. SO HE REMOVED HINGE WITH SLEEVE, STEM AND POLY AND REPLACED WITH A NEW HINGE, CEMENTED STEM AND POLY. I DON¿T KNOW WHEN OR WHERE IT WAS PREVIOUSLY IMPLANTED AND COULDN¿T LOCATE SOME OF THE LOT NUMBERS ON THE IMPLANTS. DOI: (B)(6) 2013. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 10356980 ↗