S-ROM NOILES 62-3411RRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295179498), received between Jul 14, 2017 and Apr 23, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE. IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24965802 ↗
• InjuryJan 22, 2026Fracture

  IT WAS REPORTED THAT SROM NRHFEM W/PIN SM RT 66X62 AND LPS UNIV TIB HIN INS SM 31MM WERE INVOLVED IN A REPORTED EVENT DURING A KNEE SURGERY. THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SUSPECTED FRACTURE OF THE HINGE FEMUR IMPLANT, SPECIFICALLY AT THE BOSS WHERE THE HINGED FEMUR ATTACHES TO THE FEMORAL SLEEVE AT THE MORSE TAPER LOCKING INTERFACE. A LARGE PORTION OF THE FRACTURED IMPLANT REMAINED LODGED IN THE UNIVERSAL FEMORAL SLEEVE, NECESSITATING REMOVAL OF BOTH THE SLEEVE AND STEM. ADDITIONALLY, A PACKAGING ISSUE WAS NOTED WITH THE LPS UNIV TIB HIN INS SM 31MM IMPLANT, AS ITS INNER PACKAGING WAS CRACKED; THE IMPLANT WAS USED BECAUSE NO ALTERNATIVE WAS AVAILABLE, AND THE PREVIOUSLY INTENDED IMPLANT WAS DROPPED. THE SROM NRHFEM W/PIN SM RT 66X62 WAS IMPLANTED, AND THE LPS UNIV TIB HIN INS SM 31MM WITH DAMAGED PACKAGING WAS ALSO IMPLANTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR INJURY RELATED TO THE PACKAGING EVENT, BUT THE IMPLANT FRACTURE REQUIRED CORRECTIVE INVASIVE SURGERY FOR DEVICE REVISION AND REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24146007 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. 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: RIGHT. TREATMENT/IMPACT:: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23325764 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED WITH I&D WITH POLY EXCHANGE DUE TO INFECTION. CULTURES PENDING. STREPTOCOCCUS IS BELIEVED TO BE THE ORGANISM. THE HINGE PIN ON THE SMALL FEMUR; WAS REPLACED AS WELL. THERE WAS NO REPORTED LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15595372 ↗
• InjuryApr 27, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DELIVERY OF ALL THE INSTRUMENTATION AND IMPLANTS, EXCEPT THE NOILES FEMUR IMPLANTS. NO POSSIBILITY TO TROUBLESHOOT AROUND THE CLINIC BECAUSE THE ONLY DEPOT IS IN OTHER CITY ((B)(6)). SURGERY INITIATED AT 2PM AND COMPLETED AT 6PM. THE SURGEON MADE THE DECISION TO PERFORM THE SURGERY, PERFORMED THE BONE CUTS AND TESTS, THEN PUT A SPACER IN PLACE FOR RE-OPERATION ON (B)(6) 2022 WITH THE REMOVAL OF THE SPACER AND THE INSTALLATION OF THE FINAL IMPLANTS. THE IMPLANTS WERE CHECKED ONLY AT THE TIME OF THE INTERVENTION BY THE J&J TECHNICAL ADVISOR, WHO WARNED THE SURGEON AS SOON AS SHE HAD DISCOVERED IT. THE IMPLANT KITS COULD NOT HAVE BEEN SHOWN AS MISSING ON THE DELIVERY FORM AS IT WAS NOT RESERVED. SEVERAL ELEMENTS INVOLVED, INCLUDING THE LACK OF STAFF OF THE TEAM READY TO SUSTAIN QUALITY WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218075 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED THE 23MM POLY AND SMALL RIGHT FEMORAL COMPONENT. THOROUGH WASHOUT WAS PERFORMED TO THE KNEE. SURGEON REIMPLANTED A SIZE SMALL RIGHT FEMORAL COMPONENT. UPON CEMENT HARDENING, THE SURGEON RE-TRIALED THE SIZE 23MM INSERT AND FOUND IT TO BE LOOSE. HE TRIED A SIZE 26MM INSERT AND FOUND IT TO BE SATISFACTORY. THE REAL 26MM SMALL INSERT WAS OPENED AND INSERTED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8361573 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FEMUR FRACTURE.

  Patient problems: No Code Available

  MAUDE report 8064408 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7120843 ↗
• InjuryJul 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6713387 ↗

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-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-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-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-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