S-ROM NOILES 63-3806ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295180708), received between Jun 14, 2019 and Dec 21, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT THE DEVICE WAS BROKEN INTO 2 PIECES. THERE WAS NO DELAYS IN SURGERY. AND NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379796 ↗
• MalfunctionMar 29, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE IMPACTOR SLIDE IS STUCK. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636252 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT WHEN IMPACTING THE LPS FEMORAL COMPONENT FOR FINAL IMPLANTATION, THE CONNECTION BETWEEN THE LPS UNIVERSAL HANDLE BROKE AND THE IMPACTOR HEAD SEPARATED FROM THE IMPACTOR HANDLE. IT WAS NOTED THE FAILURE OCCURRED AT THE UNIVERSAL HANDLE CONNECTION SIDE OF THE INTERFACE. THE SURGEON USED JUST FEMORAL DRIVER PORTION TO FINALIZE IMPLANTATION OF THE IMPLANT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327961 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS PC CAPTURES THE S-ROM FEMORAL DRIVER THAT WOULD NOT CONNECT TO THE SROM UNIVERSAL HANDLE QUICK RELEASE. IT WAS REPORTED THAT THERE WAS A LEFT-SIDED PERIPROSTHETIC NONUNION FRACTURE PROXIMAL TO THE CONSTRAINED TKA. ALSO, THE S-ROM FEMORAL DRIVER WOULD NOT CONNECT TO THE SROM UNIVERSAL HANDLE QUICK RELEASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924974 ↗
• MalfunctionOct 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPACTOR HANDLE WILL NOT CONNECT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598360 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE POSTS USED TO PULL BACK THE SPRING LOADED ATTACHMENT ON THE BROACH HANDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274388 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEPUY OFFICE PERSONNEL CALLED TO MAKE AWARE, IMPACTOR WILL NOT RELEASE FROM THE HANDLE. THE INSTRUMENT WORKED FINE IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690138 ↗
• MalfunctionAug 24, 2020Break; Break

  REVISION KNEE REPLACEMENT; THE SURGEON WAS IMPACTING A DISTAL FEMUR WHEN THE IMPACTOR BROKE. ACTION TAKEN TO MANAGE THE ISSUE: USED A SECOND HANDLE THAT WAS AVAILABLE WITHIN THE SAME KIT. NO AE TO PATIENT. NO DELAY TO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10444514 ↗
• MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO SURGICAL DELAY NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396384 ↗
• MalfunctionJun 14, 2019Break; Break

  IT WAS REPORTED THAT THE HANDLE WAS BROKEN, ALL PIECES WERE FOUND. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699996 ↗