S-ROM NOILES 62-1641Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295179115), received between Jul 6, 2017 and Jul 25, 2024 — classified as 5 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 5 most recent of 5 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 19827886 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOE: (B)(6) 2020 - (B)(6) 2022: PATIENT CONTINUED TO HAVE CHRONIC RIGHT KNEE PAIN, WALKING DIFFICULTY, REDUCED ROM, AND SWELLING AFTER REVISION. PATIENT RECEIVED A RIGHT KNEE ULTRASOUND WITH ASPIRATION AND CORTICOSTEROID INJECTION COMBINED WITH CONTINUED PHYSICAL THERAPY, WHICH WAS INEFFECTIVE. BETWEEN (B)(6) 2020 AND (B)(6) 2022, THE PATIENTS PAIN MANAGEMENT PHYSICIAN ADMINISTERED 7 KETAMINE INFUSIONS TO TREAT HIS RIGHT KNEE CHRONIC REGIONAL PAIN SYNDROME (CRPS). THE PATIENT ALSO RECEIVED A RIGHT KNEE GENICULAR NERVE RADIOFREQUENCY ABLATION (RFA) ON (B)(6) 2022. THERE WERE NO ALLEGATIONS OF PRODUCT DEFECTS NOR WERE THERE ANY REVISION SURGERIES PERFORMED. ALL PROCEDURES WERE ADMINISTERED TO TREAT THE PATIENTS ONGOING CHRONIC PAIN, SWELLING, REDUCED ROM, AND WALKING DIFFICULTY AND WILL BE CAPTURED AS ONE EVENT DOI: (B)(6) 2019 (TIBIAL TRAY). (B)(6) 2019 (TIBIAL INSERT). (B)(6) 2020 (FEMORAL COMPONENT). DOE: (B)(6) 2020.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14317240 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. LINER AND PIN EXCHANGED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10613053 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN I&D WITH LINER CHANGE FOR INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8500174 ↗
• InjuryJul 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6688902 ↗