S-ROM NOILES 63-3805ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295180692), received between Jan 8, 2019 and Feb 12, 2026 — classified as 9 malfunctions.

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

• MalfunctionFeb 12, 2026Detachment of Device or Device Component; No Apparent Adverse Event

  ADDITIONAL INFORMATION STATES: CAN YOU PLEASE CLARIFY THE EXACT ALLEGATIONS AGAINST THE REPORTED PRODUCT? DID IT BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, DULL, WORN OR CROSS THREADED? MOST OF THEM HAVE JUST WEAR AND TEAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321444 ↗
• MalfunctionSep 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE ASSEMBLING THE FEMORAL SLEEVE AND STEM TO THE ADAPTOR AND DISTAL FEMUR THE S-ROM IMPACTOR CAP GOT STUCK ON THE STEM. SURGEON HAD TO USE A SAW TO GET THE IMPACTOR LOOSE FROM THE STEM. THE IMPLANTS WERE NOT DAMAGED. SURGERY WAS NOT DELAYED. THE IMPACTOR CAP WAS DAMAGED AND NEEDS TO BE REPLACED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182150 ↗
• MalfunctionJul 11, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE IMPACTION CUP HAD DAMAGE ON THE INNER RIM THAT IS FLAKING OFF. THE LPS INSERTER/EXTRACTOR'S INTERNAL ROD IS BENT AND WEAR AND TEAR SCRATCHES ON IT MAKING IT HARD TO INSERT INTO THE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720493 ↗
• MalfunctionJul 9, 2024Break; Naturally Worn; Break; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: THE INSTRUMENT IS A BLUE PLASTIC HOLLOW IMPACTOR. THE INTERNAL SURFACE WAS ROUGHENED AND WHEN IT CAME INTO CONTACT WITH THE IMPLANT DURING IMPACTION, THE PLASTIC RUBBED OFF THE IMPACTOR AND ONTO THE SURFACE OF THE IMPLANT. THIS ITEM IS USED ON THE BACK TABLE TO PUT THE IMPLANTS TOGETHER SO FRAGMENTS DO NOT FLAKE OFF INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706521 ↗
• MalfunctionJan 18, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE IMPACTOR CAP, THE PLASTIC IS CHIPPED FROM IMPACTION OF THE CEMENTED STEM AND DISTAL FEMUR MATING TOGETHER. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196679 ↗
• MalfunctionMar 9, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE LPS STEM INSERTER IS BENT AND WILL NOT WORK, AND NEEDS TO BE REPLACED. THE BLUE SROM IMPACTION PIECE IS DAMAGED ON THE INSIDE DUE TO EXCESSIVE WEAR AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446296 ↗
• MalfunctionNov 19, 2020Component Missing; Naturally Worn; Component Missing; Naturally Worn

  THE INSTRUMENT IS PLASTIC, SO IT APPEARS TO HAVE BEEN DAMAGED DURING USAGE AND HAS A PIECE MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10867878 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT THE IMPACTOR LPS WAS DAMAGED DUE TO BREAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129581 ↗
• MalfunctionJan 8, 2019Break; Break

  THE SROM IMPACTOR IS CHIPPED/TORN UP ON THE EDGES/INSIDE AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227328 ↗