S-ROM NOILES 62-3411LRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295179481), received between Nov 3, 2017 and Jan 15, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K241000, K896048); they may or may not involve this specific model.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE FEMUR FOLLOWING A REVISION TOTAL KNEE ARTHROPLASTY. X-RAYS REVEALED LUCENCY AROUND THE FEMORAL SLEEVE AND REMODELING IN THE FEMUR AROUND THE STEM, SUGGESTING LOOSE COMPONENTS. THE TIBIAL COMPONENTS APPEARED TO BE WELL FIXED AND SLEEVE APPEARED TO BE INGROWN. A FEMORAL SIDE REVISION WAS PERFORMED WITH NO DELAY AND NO PATIENT HARM. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort

  MAUDE report 24082022 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: 15 SEP 2025 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23327539 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HINGE KNEE DONE ON (B)(6) 2024. PATIENT HAD A STATIC SPACER IN FOR AROUND 2 YEARS BEFORE WHICH WAS DONE AT ANOTHER HOSPITAL. PATIENT GREW SOME SORT OF STAPH. HINGE PIN AND LINER WERE REMOVED AND REPLACED WITH NEW AFTER A THOROUGH I&D. FEMORAL COMPONENT WAS LEFT AND TIBIAL COMPONENT WAS LEFT. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19754839 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND HAD TO REMOVE IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18074299 ↗
• InjuryMar 13, 2023Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE AN ALLEGATION AGAINST THE X-SMALL HINGE INSERT? OR THE S-ROM NOILS FEMUR? IF THE X-SMALL HINGE INSERT, PLEASE PROVIDE THE LOT AND PRODUCT NUMBER. THERE WERE NO ISSUES WITH THE X-SMALL INSERT ONLY THE S-ROM NOILS FEMUR WAS MISMATCHED B. PLEASE CLARIFY IF THIS IS A PRIMARY SURGERY OR A REVISION SURGERY. IF A REVISION: IT WAS A REVISION SURGERY. B1. PLEASE PROVIDE THE PRIMARY SURGERY DATE. PRIMARY WAS PERFORMED 10 YEARS BEFORE SOMEWHERE ELSE. B2. REASON FOR REVISION IMPLANT WAS LOOSED (THAT¿S WHY THE REVISION WAS REQUIRED).

  Patient problems: Insufficient Information

  MAUDE report 16528904 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE PLACED ON (B)(6) 2022 AND WAS WASHED OUT WITH PIN AND POLY EXCHANGED ON (B)(6) 2023. PATIENT HAD A STATIC SPACER PLACED DUE TO INFECTION. THERE WAS NO PATIENT HARM OCCURRED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16269688 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN EMERGENCY ROOM WITH A DRAINING KNEE. PATIENT BROUGHT TO OPERATING ROOM FOR I&D WITH POLY EXCHANGE AND PLACEMENT OF ANTIBIOTIC RESORBABLE BEADS. THE HINGE PIN WAS EXCHANGED FROM THE LISTED FEMORAL COMPONENT BUT THE FEMORAL COMPONENT WAS RETAINED. INFECTION CANNOT BE CONFIRMED AT THIS TIME. NO PATIENT HARM OCCURRED. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 16225508 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR WAS REMOVED AND REPLACED AND EXTERNAL ROTATION ADDED. THERE WAS NO SURGICAL DELAY. THE CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15751166 ↗
• InjurySep 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WITH A HINGE SROM KNEE FELL AND LOOSENED THE FEMORAL COMPONENT FROM THE SLEEVE. THE PATIENT HAS NO FUNCTIONING QUAD OR PATELLA. RIGHT. OLD HINGE FEMUR AND INSERT WERE REMOVED AND A NEW ONE WAS REPLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2022.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 15397609 ↗
• InjuryJul 27, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION SURGERY: (B)(6) 2009 PATIENT (R) SIDE REVISION OF COMPETITOR PRODUCTS (UNKNOWN IMPLANTS REVISED). REVISION SURGERY: (B)(6)2010 PATIENT (L) SIDE REVISION OF COMPETITOR PRODUCTS (UNKNOWN IMPLANTS REVISED). REVISION SURGERY: (B)(6) 2022 PATIENT (L) REVISION OF DEPUY PRODUCTS: FEMORAL COMPONENT LOOSE AND NEEDED REVISION. IMPLANTS INSITU (AFFECTED ITEMS LISTED FOLLOWING UNDER 8.3.2010 - REFER TO SOURCE DATA). FEMORAL COMPONENTS REMOVED AND REVISED TO LARGER STEM AND SLEEVE. EXISTING PLATEAU RE USED. TIBIA REMAINS INSITU.

  Patient problems: Insufficient Information

  MAUDE report 15112741 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD KNEE DISCOMFORT AND KNEE STIFFNESS. IMPLANTS REMOVED AND WENT WITH A SMALLER FEMORAL COMPONENT AND THINNER POLY. ORIGINAL IMPLANT DATE UNKNOWN. BONE CEMENT WAS NOT INDICATED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SIDE.

  Patient problems: Discomfort; Muscular Rigidity

  MAUDE report 14238145 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO THE LEFT-SIDED PERIPROSTHETIC NONUNION FRACTURE PROXIMAL TO THE CONSTRAINED TKA. DOI: UNKNOWN - DOR: (B)(6) 2021 (LEFT KNEE).

  Patient problems: Limb Fracture

  MAUDE report 12924923 ↗
• InjuryNov 5, 2020Loss of or Failure to Bond; Fracture; Loss of Osseointegration; Loss of or Failure to Bond; Fracture; Loss of Osseointegration

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SROM FEMUR AT THE BONE TO IMPLANT INTERFACE. POST OF SROM HINGE FEMORAL COMPONENT BROKE IN-SITU AND PART OF POST WAS STUCK IN UNIVERSAL FEMORAL SLEEVE. SURGEON BELIEVES IT BROKE UNDER PRESSURE. SURGEON HAD TO REMOVE FEMORAL SLEEVE AND PRESS FIT STEM. FEMUR WAS REVISED. DOI: (B)(6) 2017. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Insufficient Information; No Code Available

  MAUDE report 10792900 ↗
• InjuryJul 7, 2020Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS PATELLAR TRACKING ISSUES AND PAIN. AN SROM NOILES FEMUR WAS SWITCHED OUT FOR AN LPS DISTAL FEMORAL COMPONENT AND +10 TAPERED ADAPTER. THE POLY WAS DOWNSIZED FROM A 26MM TO A 12MM. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10239324 ↗
• InjuryNov 3, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS FRACTURE OF THE TIBIAL TRAY AND STEM. IT WAS ALSO CLEAR THE FEMUR WAS ALSO LOOSE OF THE FEMORAL COMPONENT. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Inadequate Osseointegration; No Information

  MAUDE report 7000201 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K896048. One submission often covers many models, so check the product and lot details in each record.

• Z-1208-2014 · Feb 24, 2014 · Terminated
  REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision
• Z-1206-2014 · Feb 24, 2014 · Terminated
  REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision su
• Z-1207-2014 · Feb 24, 2014 · Terminated
  REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision
• Z-1205-2014 · Feb 24, 2014 · Terminated
  REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision su
• Z-1203-2014 · Feb 24, 2014 · Terminated
  REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision su
• Z-1204-2014 · Feb 24, 2014 · Terminated
  REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision