S-ROM NOILES 62-3401RRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295179474), received between Sep 15, 2017 and Jan 7, 2026 — classified as 23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE AND STABILITY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PREVIOUS TRAUMATIC INJURY. THE PREVIOUS IMPLANTS WERE UPSIZED BECAUSE OF LOOSENING IN THE TIBIA AND FEMUR AND THE ACTUAL POLYETHYLENE WAS NOT WORN OUT. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23992711 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT COMPLEX PRIMARY KNEE REPLACEMENT ON (B)(6) 2023 REQUIRING NOILES HINGE REPLACEMENT DUE TO MULTIPLE PREVIOUS LIGAMENT INJURIES. SUBSEQUENT TRAUMATIC PATELLA FRACTURE REQUIRING RECONSTRUCTION AND PRESENTED (B)(6) 2024 WITH PROSTHETIC JOINT INFECTION REQUIRING REMOVAL OF ALL COMPONENTS AND FUSION SPACER. IMPLANTS REVISED AND CEMENT SPACER IMPLANTED AS TEMPORARY MEASURE WHILST INFECTION TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 20613287 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION OF RIGHT KNEE. DOI: (B)(6) 2020. DOR: (B)(6)2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20440014 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION WAS COMPLETED DUE TO INFECTION. POLY LINER AND HINGE PIN WERE REVISED AND WASHOUT WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19839409 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION WAS COMPLETED TO ADDRESS INFECTION. WASH OUT WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19815756 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE REPLACEMENT: REVISING ATTUNE CR RP CEMENTED. CONVERTED TO PS RP CEMENTED. DOI: (B)(6) 2024; DOE: (B)(6) 2024. ADDITIONAL EVENT DESCRIPTION: PRIMARY (MEDACTA) KNEE HAD INFECTION, REVISED TO SROM HINGE, PERSISTENT INFECTION, RV WASHOUT OF SROM HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 19740681 ↗
• InjuryNov 18, 2022Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO PATIENT FALLING ON HIS KNEE. UPON EXPOSURE TO THE JOINT SPACE IT WAS DISCOVERED THAT MEDIUM SROM HINGED FEMUR HAD LOOSENED AWAY FROM THE POROUS FEMORAL SLEEVE CONSTRUCT. THE LOOSENING OCCURRED AT THE TAPER POINT OF THE FEMUR TO THE SLEEVE. SURGEON REMOVED THE STILL ENGAGED HINGED PIN WITH A PAIR OF KOCHERS AND THEN REMOVED THE MEDIUM X 26MM POLY WITH HIS HAND AND THEN REMOVED THE MEDIUM RIGHT FEMUR BY HAND. UPON FURTHER EXAMINATION THE SURGEON STATED THAT NONE OF THE IMPLANTS HAD BROKEN OR SHOWN UNUSUAL WEAR BUT HAD SIMPLY DISENGAGED AS A RESULT OF THE FALL THE PATIENT EXPERIENCE. THE TIBIAL COMPONENT AND FEMORAL SLEEVE/STEM WERE WELL FIXED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Pain; Unspecified Infection

  MAUDE report 15829291 ↗
• InjuryOct 7, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THE INITIAL PROCEDURE ON THE (B)(6) 2022 (RECEIVED AN S-ROM NOILES ROTATING HINGE KNEE). THE PATIENT FELT HIS KNEE "GIVE WAY", FOLLOWED BY SIGNIFICANT PAIN. UPON INVESTIGATION IT WAS DISCOVERED THAT THE "BOSS" FOR THE SLEEVE ATTACHMENT ON THE FEMORAL COMPONENT HAD BROKEN RESULTING IN FAILURE OF THE CONSTRUCT. THE PATIENT UNDERWENT REVISION SURGERY AND THE DAMAGED FEMORAL COMPONENTS WERE REMOVED AND REVISED TO AN LPS DISTAL FEMORAL REPLACEMENT. THE RETRIEVED IMPLANTS WERE SENT TO THE BIO-ENGINEERING DEPARTMENT AT ROYAL PERTH HOSPITAL AS PER STANDARD PROTOCOL HERE IN WA. IF OTHER, DESCRIBE. N/A. IF OTHER, DESCRIBE. REVISION KNEE SURGERY. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN, INFLAMMATION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: X-RAYS, REVISION SURGERY. OTHER INFORMATION: N/A. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION O

  Patient problems: Fall; Inflammation; Joint Laxity; Pain

  MAUDE report 15566429 ↗
• 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 14218063 ↗
• InjuryApr 25, 2022Fracture; Fracture

  NOILES FEMORAL IMPLANT BROKEN ON THE SLEEVE CONNECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 14192363 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6)2021. DOR: (B)(6)2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14101651 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WAS THE CEMENT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PRODUCT AND LOT NUMBERS. NO, PALACOS CEMENT WAS USED IN THE PREVIOUS OPERATION. 2. IT WAS MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD A REVISION OF HER RIGHT KNEE BY (B)(6) ON THE (B)(6) 2019. DID THIS REVISION INVOLVE EXPLANTATION OF DEPUY PRODUCTS? IF SO, WAS THIS REVISION REPORTED? (IF THIS REVISION HAS BEEN PREVIOUSLY REPORTED PLEASE PROVIDE THE PC # IF KNOWN). NO, IT WAS A COMPETITOR KNEE REPLACEMENT THAT WAS REVISED. 3. IT WAS INDICATED THAT LOOSENING WAS DUE TO INFECTION. CAN YOU PLEASE ADVISE THE LOOSENING COMPONENT/S AND LOOSENING INTERFACE? THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE BONE CEMENT INTERFACE AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA, THERE WAS ALSO SOME LOOSENING AROUND THE FEMORAL SLEEVE. 4. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12235661 ↗
• InjuryJul 2, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT AN UNKNOWN INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: Pain

  MAUDE report 12108543 ↗
• InjuryApr 28, 2021Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS A DISLOCATED TOTAL KNEE AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THE SURGEON ELECTED TO REVISE THE KNEE BY SWITCHING THE POLY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 11737063 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE KNEE WAS OPENED AND THE OLD SROM HINGED COMPONENTS REMOVED AND THESE WERE REPLACED WITH AN ATTUNE REVISION TRAY (AS FULLY POROCOATED TIB SLEEVES ARE AVAILABLE) A CROSSOVER ATTUNE LPS BEARING UTILIZED (AVAILABLE ON SAS) AND A FRESH S ROM HINGE IMPLANTED, ALONG WITH A NEW PATELLA COMPONENT. REMOVAL OF ALL COMPONENTS DUE TO FUNGAL INFECTION.

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

  MAUDE report 11705674 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004, THE PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY DUE TO ARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2011, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, COMPARTMENT SYNDROME, DISLOCATION, INSTABILITY, AND ABSCESS. ALL COMPONENTS WERE NOTED TO BE REMOVED AND REPLACED WITH ARTICULATING ANTIBIOTIC SPACER. UNKNOWN MANUFACTURER PRODUCTS WERE IMPLANTED DURING THE REVISION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Joint Laxity

  MAUDE report 11334406 ↗
• InjuryJan 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS A DISLOCATED HINGED KNEE. THE SURGEON ELECTED TO REVISE THE IMPLANTS. DOI: (B)(6) 2018; (B)(6) 2019 ( FEMUR AND INSERT). DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 11224034 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE IMPLANTATION DATE OF THE RIGHT KNEE WAS (B)(6) 2019.

  Patient problems: Edema; Erythema; Injury; No Code Available; Not Applicable; Pain

  MAUDE report 10283407 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TKA UTILIZING AN S-ROM HINGE IMPLANT. THE PATIENT HAD A POLY SWAP DUE TO INFECTION ON (B)(6) 2019. THE PATIENT FRACTURED HIS FEMUR AT SOME POINT AND THE SURGEON FEARS THAT THE PATIENT IS STILL INFECTED SO HE WANTED TO DO A DISTAL FEMUR REPLACEMENT. THE FEMUR WAS REMOVED WITH THE SLEEVE AND STEM INTACT. THE SURGEON RESECTED MORE DISTAL FEMUR, CABLED THE FEMORAL SHAFT, BROACHED USING THE LPS DISTAL FEMUR REPLACEMENT AND USED STIMULAN BEADS. THE SURGEON WAS HAPPY WITH THE EXTENSION GAP AND PATELLA TRACKING. DOI: (B)(6) 2018; DOI: (B)(6) 2019 (INSERT); DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection

  MAUDE report 10275621 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9874281 ↗
• InjuryJan 24, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THE PLAN FOR POLY SWAP, BUT DUE TO PATIENT RISK FACTORS, FEMUR IS LOOSE AT THE BONE TO IMPLANT INTERFACE, SO CLOSING TO REASSESS PLANS AND POSSIBLE TWO STAGE OR AMPUTATION AT LATER DATE. PATIENT NOT CONSENTED TO REVISE ALL COMPONENTS TODAY. DOI: (B)(6) 2017; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Not Applicable

  MAUDE report 9629143 ↗
• InjuryApr 22, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND FEMORAL SLEEVE AT BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS REVISED. DOI: (B)(6) 2013; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8536957 ↗
• InjurySep 15, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND FEMORAL SLEEVE LOOSENING. LOOSENING OCCURRED FROM BONE TO IMPLANT INTERFACE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6868081 ↗

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-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-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
• 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-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-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