S-ROM NOILES 62-3421LRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295179504), received between Aug 10, 2017 and Dec 16, 2025 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEHISCED KNEE FROM PREVIOUS SURGERY. PATIENT WAS WASHED OUT AND WOUND WAS REVISED. THE DOCTOR DECIDED TO REPLACE POLY DURING I&D OF THE JOINT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 23817557 ↗
• InjuryDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THE S-ROM FEMUR COMPONENT CEMENTED? - THERE WAS SIGNIFICANT BONE LOSS SO IT APPEARS THE SROM FEMUR WAS NOT ABLE TO BE CEMENTED. B. WAS THE SLEEVE IMPLANT WELL-FIXED? - THE SLEEVE WAS WELL FIXED. C. WAS THE FEMUR TO SLEEVE MORSE TAPER CONNECTION SOLID, OR HAD IT COME LOOSE/LOST ITS MORSE TAPER FIXATION? D. WHAT IS THE EXACT ALLEGATION AGAINST ATTUNE REV LPS INSRT XSM 20MM? - IT SEEMED ALL THE STRESS PLACED ON THE TAPER HAD CAUSED THE FEMUR TO LOOSEN FROM THE SLEEVE. E. PLEASE PROVIDE THE LOT NUMBER AND PRODUCT CODE FOR UNK KNEE FEMORAL SLEEVE. - NO ALLEGATION REGARDING THE INSERT, BUT IT WAS REMOVED AND REPLACED.

  Patient problems: Bone Notching; Fluid Discharge; Foreign Body Reaction; Joint Laxity; Swelling/ Edema

  MAUDE report 23749393 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF THIGH PAIN. THERE WAS A LUCENCY AROUND THE STEM ON X-RAY. OPERATIVELY, THE SLEEVE WAS WELL FIXED BUT SURGEON WAS CONCERNED AND REMOVED ALL FEMORAL COMPONENTS. TIBIAL COMPONENT APPEARED TO BE WELL FIXED AND WAS LEFT IN PLACE. A DISTAL FEMORAL REPLACEMENT WAS PLACED WITHOUT DELAY OR PATIENT HARM. DOI- (B)(6) 2017. DOR- (B)(6) 2025. AFFECTED SIDE-LEFT SIDE.

  Patient problems: Pain

  MAUDE report 23584892 ↗
• InjuryJul 7, 2025Adverse 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 INSTABILITY. UPON EXPLANT, IT WAS REALIZED THE STEM AND SLEEVE JUNCTION WAS BROKEN. SURGEON REPORTED A FALL PRIOR TO REPORTS OF INSTABILITY. THERE WAS LOOSENING OF SLEEVE AND SROM FEMUR AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22423886 ↗
• InjuryFeb 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AND TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS PROGRESSIVE LEFT KNEE PAIN. X-RAYS SHOWED LUCENCY AROUND FEMUR AND TIBIA COMPONENTS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21470565 ↗
• InjuryApr 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  J-C HEALTH CARE LTD. RECEIVED ON 9 APRIL 2024 A DEMAND LETTER DATED 28 MARCH 2024 PERTAINING TO A TOTAL KNEE REPLACEMENT WITH SIGMA IMPLANT. ACCORDING TO THE DEMAND LETTER, BACK IN 2019 PATIENT UNDERWENT A LT TKR IN RUSSIA (UNKNOWN IMPLANT) AND SUFFERED FROM INFECTION. THEREAFTER PATENT UNDERWENT SEVERAL INFECTION REVISIONS (ALSO IN RUSSIA) INCLUDING REMOVAL OF TIBIAL IMPLANT AND INSERTION OF SPACER, THAT DID NOT SOLVE THE INFECTION. DURING (B)(6) 2020 PATIENT WAS TREATED AT (B)(6) IN ISRAEL. ON (B)(6) 2020 (B)(4) CAPTURED FOR THE 1ST REVISION) PATIENT UNDERWENT A FIRST STAGE OF LT TKR REVISION AT SHEBA MEDICAL CENTER DUE TO "INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS (LEFT)" DURING WHICH HER IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THEREAFTER PATIENT WAS PLACED IN PLASTER CAST/BRACE AND KNEE FIXATION AND RECEIVED A LONG TERM SYSTEMIC ANTIBIOTIC TREATMENT UNDER LABORATORY MONITORING. AFTER 6 WEEKS OF ANTIBIOTIC TREATMENT WITH VANCOMYCIN AND LABORATORY MONITORING FOR ADDITIONAL 2 MONTHS, IT WAS FOUND THAT THERE WAS NO INFLAMMATION OF THE INFECTION FOLLOWING CESSATION OF THE ANTIBIOTICS AND THE KNEE WAS "QUIET", THE SECOND STAGE OF THE R

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 19173448 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND RUPTURED HER QUADRICEPS AGAIN. A RECONSTRUCTION OF HER QUADRICEPS TO INCLUDE ALLOGRAFT WAS PERFORMED ALONG WITH THE EXCHANGE OF COMPONENTS. PATELLA IMPLANT (A NON JNJ PRODUCT) WAS REMOVED AND REPLACED AS IT HAD BEEN CUT AT AN ANGLE AND WAS THICKER THAN THE SURGEON THOUGHT WAS APPROPRIATE. SURGEON ROUTINELY USES DEPUY 2 WITH GENT FOR REVISION CASES BUT NO RECORDS ARE AVAILABLE AS CEMENT IS HOSPITAL OWNED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 14787834 ↗
• InjuryNov 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  TODAY A FULL NOILES CONSTRUCT WAS REVISED. THE REASON FOR THE REVISION WAS FOR ASEPTIC LOOSENING OF THE EXISTING IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12758550 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF HINGE PIN FOR INFECTION IN PATIENT. SROM FEMUR OPENED TO OBTAIN HINGE PIN AS ONLY WAY TO SUPPLY HINGE PIN.

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

  MAUDE report 11862931 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY AND HINGE PIN EXCHANGE FOR INFECTION OF LEFT TOTAL KNEE REPLACEMENT. ORIGINAL SURGERY DATE WAS (B)(6) 2019 AT (B)(6) HOSPITAL.

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

  MAUDE report 11332005 ↗
• MalfunctionJan 27, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED ONE HINGE PIN WAS NOTED AS DEFECTIVE UPON OPENING PACKAGING AND IT DID NOT FIT CORRECTLY. THE OTHER PIN WITHIN PACKAGE WAS NOTED AS NOT DEFECTIVE. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236900 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERI PROSTHETIC FRACTURE. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11147128 ↗
• InjuryOct 26, 2020Unintended Movement; Unintended Movement

  THESE WERE REVISED DUE TO THE PATIENT COMPLAINING OF PAIN WHICH WAS DETERMINED TO BE CAUSED BY THE STEM TIP BEING IN CONTACT WITH THE CORTICAL BONE. THE ORIGINAL SURGERY WAS COMPLETED IN (B)(6) 2020. THE EXPLANTS ARE NOT AVAILABLE FOR REVIEW. IF X-RAYS ARE REQUIRED THEY MAY NOT BE AVAILABLE AS THE PATIENTS PERMISSION WILL BE REQUIRED. THE SURGEON DOES NOT REQUIRE ANY FOLLOW-UP.

  Patient problems: No Code Available; Pain

  MAUDE report 10733086 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. SURGEON REMOVED EVERYTHING. DOI: (B)(6) 2019; (INSERT). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9891425 ↗
• InjuryFeb 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SROM BINGE FEMUR WAS DISASSOCIATED FROM THE SLEEVE. REVISION SURGERY IS BEING PERFORMED TO REMOVE AND REPLACE THE IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9681467 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9122988 ↗
• InjuryAug 7, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT, BONE TO CEMENT AND BONE TO IMPLANT INTERFACES. UNKNOWN CEMENT WAS USED. THE PATIENT HAD A KNEE REVISION IN 2014 AND RECEIVED SROM HING KNEE. THE SURGEON EXPLANTED THE NOILES HINGE FEMUR, FEMORAL SLEEVE, FEMORAL STEM, AND LPS POLY AND IMPLANTED A LPS DISTAL FEMUR, STEM AND A STEM. SOME LOT NUMBERS OF THE EXPLANTED IMPLANTS WERE NOT LEGIBLE. DOI: (B)(6) 2014; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8871019 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REVISION SURGERY ON (B)(6) 2019, THE REVISING SURGEON IDENTIFIED, FOLLOWING PLACEMENT OF THE REVISED TIBIAL CONSTRUCT, THAT THE PATIENT NOW HAD PATELLA BAJA. BECAUSE THE PREVIOUSLY IMPLANTED S-ROM HINGED FEMUR CONSTRUCT (INCLUDING METAPHYSEAL SLEEVE AND STEM) WAS WELL-FIXED, IT WAS DETERMINED THAT REVISING THE FEMUR, WITH THE POTENTIAL DESTRUCTIVE BONE LOSS THAT COULD ENSUE, WAS NOT DEEMED ACCEPTABLE. THE PATELLA WAS NOTED TO TRACK WELL OTHERWISE, BUT THE PATELLA BAJA REMAINED UNTREATED. (LEFT KNEE).

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 8678650 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AT PHYSICAL THERAPY AND FRACTURED ENTIRE DISTAL FEMUR AROUND EXISTING SROM HINGE COMPONENT. ABLE TO KEEP THE TIBIAL COMPONENT BUT REMOVED THE SROM FEMUR AND PUT IN AN LPS. NO X RAYS AVAILABLE. DOI: (B)(6) 2019 DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8584893 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS DISCOVERED THE PATIENT EXPERIENCED AN INTRA-OPERATIVE FEMORAL FRACTURE DURING REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8004481 ↗
• InjuryFeb 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. WASH OUT WITH POLY WAS DONE. DOI: (B)(6) 2017, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7247019 ↗
• InjuryJan 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT ALSO STATES THAT A SPACER BLOCK WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7177081 ↗
• InjuryAug 10, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE SROM FEMUR, FEMORAL SLEEVE AND UNIVERSAL STEM AT THE IMPLANT TO BONE INTERFACE.

  Patient problems: No Information

  MAUDE report 6784095 ↗