S-ROM NOILES 62-1640Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295179108), received between Dec 3, 2017 and Jun 10, 2026 — classified as 49 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS INFECTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25461496 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PREVIOUS LEFT DFR REPLACEMENT. PATIENT HAD ALSO HAD A PREVIOUS I&D DONE TWO YEARS AGO. SHOWING SIGNS OF INFECTION AND BROUGHT IN FOR I&D WITH INSERT EXCHANGE. NO COMPLAINTS OR DELAYS IN SURGERY. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25436037 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. WASH OUT AND POLY SWAP WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24823072 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON REPLACED POLY AND HINGE PIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22592893 ↗
• InjuryJul 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED FOR 6 MONTHS POST OP. I&D AND REPLACED LOCKING PIN WAS OCCURRED. DOI: (B)(6) 2025. DOR:(B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22485623 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21984099 ↗
• InjuryApr 21, 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 KNEE INFECTION. AN I&D WAS PERFORMED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21872013 ↗
• InjuryApr 17, 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 INFECTION. I&D WAS PERFORMED AND INSERT AND PIN WERE SWAPPED OUT. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21853980 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NO ISSUES WITH IMPLANTS OR POSITION. SURGEON STATED JOINT LINE WAS ELEVATED. DOI: (B)(6) 2016, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 20624442 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED AND THERE WAS SIGNS OF INFECTION. SO DOCTOR PERFORMED AN I&D AND POLY SWAP AND UPSIZED THE POLY AND PUT A NEW HINGE PIN IN AS WELL. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20194678 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD NO QUAD MECHANISM AND COULD DISLOCATE POLY IN DEEP FLEXION. SURGERY ELECTED TO OPEN AND CHANGE INSERT AND PIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19269418 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INSTABILTY AND POLY DISASSOCATION.

  Patient problems: Joint Laxity

  MAUDE report 19166594 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18979773 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: PAIN.

  Patient problems: Pain

  MAUDE report 18958947 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTED KNEE. NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18956509 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. THE SURGEON PERFORMED I&D AND DETERMINED THAT THE INFECTION MIGHT BE DEEP. SO HE EXCHANGED THE POLY AND HINGE PIN AS WELL. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18921510 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING ON THIGH PAIN, SURGEON WAS WORRIED ABOUT LACK OF BONE GROWTH WITHIN THE FEMORAL STEM PROSTHESIS. UPON INSPECTION, THE ENTIRE PROSTHESIS WAS REMOVED FROM THE FEMORAL SIDE AND A CEMENTED BOWED STEM WAS IMPLANTED. A LARGER INSERT WAS ALSO TRAILED AND THEN INSERTED. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18393017 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18005559 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT EXPERIENCED PAIN AND INSTABILITY. A SURGICAL TIME EXTENSION OF APPROXIMATELY 30 MINUTES ALSO OCCURED DUE TO THE PRONOUNCED PERIARTICULAR CALCIFICATIONS.

  Patient problems: Calcium Deposits/Calcification; Joint Laxity; Pain

  MAUDE report 16712062 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE LINER WAS EXCHANGED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16408762 ↗
• 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 16269689 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIRST SURGERY WAS ON THE (B)(6) 2022, AFTER STERILIZING THE MATERIAL REMOVING THE INNER BOXES, THE TRAYS AND PUTTING EVERYTHING WRAPPED IN PAPER AND ALL THE STERILE MATERIAL CAME OUT, BUT TODAY DR. (B)(6) (THE SURGEON), HAS RETURNED TO THE PATIENT, BECAUSE THE WOUND STAINED AND THEY SUSPECT THAT IT IS INFECTED, FOR THAT REASON THEY HAVE PUT IT TODAY TO OPEN THE WOUND AND WASH IT ABUNDANTLY TO SEE IF YOU CAN AVOID HAVING TO REMOVE ALL THE MATERIAL. AS I TOLD YOU, THE SURGERY OF DAY 7TH, WAS A REPLACEMENT OF A PTR THAT HAD EATEN POLYETHYLENE AND WAS TOUCHING METAL / METAL, WHICH HAD CAUSED AN ENORMOUS METALLOSIS IN THE JOINT, DURING THE SURGERY THE KNEE PROSTHESIS THAT HAD THE PATIENT WAS REMOVED, METALLOSIS WAS REMOVED AND OUR NOILES KNEE REPLACEMENT PROSTHESIS WAS IMPLANTED. AT THAT TIME THERE WERE NO MARKERS OF ANY POSSIBLE INFECTION. TODAY, AFTER TAKING SAMPLES, WASHING THE WOUND AND CLEANING IT, WE PROCEEDED TO CHANGE THE POLYETHYLENE AND THE PIN, THE REST OF THE COMPONENTS WERE MAINTAINED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE P

  Patient problems: Unspecified Infection

  MAUDE report 16131799 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15693527 ↗
• InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. LINER WAS EXCHANGED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15461892 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NEW LINER AND HINGE PIN IMPLANTED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15236941 ↗