S-ROM 2576-52-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295147299), received between May 11, 2018 and Jul 31, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE END OF CUP HANDLE BROKE OFF DURING SURGERY. THE S-ROM NUT TIGHTENER BENT DURING SURGERY. THE S-ROM PIN PUNCH BENT DURING SURGERY. THE S-ROM TRIANGLE MILLER FRAME WAS BENT DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676575 ↗
• MalfunctionMar 20, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE NUT TIGHTENER HAS GENERAL WEAR AND TEAR AT THE TOP AND WASN'T EASILY ENGAGING WITH THE NUT OF THE TRIAL BODIES OF THE SROM SYSTEM. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? STILL ABLE TO USE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943307 ↗
• MalfunctionMar 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SPD NOTED THAT THE SROM NUT TIGHTENER WAS WORN AND NOT EFFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866991 ↗
• MalfunctionApr 14, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  THE NUT TIGHTENER THREADS ARE STRIPPED AND WILL NOT SCREW ONTO THE TRIAL STEMS FOR EXTRACTION. THE ITEM WAS NOT BROKEN AND THERE WERE NO BROKEN PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111294 ↗
• MalfunctionJan 22, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE NUT TIGHTENER NO LONGER FITS INTO THE NECK SEGMENTS TO TIGHTEN THEM. REPEATED IMPACTION CAUSED THE EDGE TO BECOME BEVELED AND IT CATCHES ON THE NECK TRIAL. EVENT DID NOT CAUSE DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214849 ↗
• MalfunctionJun 24, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT AN AB GRIPPER STOCKING AND NOT REAL SONG BEARING. SROM NECK NUT TIGHTENER IS DEFORMED AND WON¿T ENGAGE NECK TRIAL .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191614 ↗
• MalfunctionNov 21, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE ENGAGE NUT TIGHTENER DEVELOPED BURR ON END, NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353489 ↗
• MalfunctionOct 9, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE EDGE OF INSTRUMENT HAS BECOME WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949458 ↗
• MalfunctionMay 11, 2018Bent; Bent

  IT WAS REPORTED THAT THE INSTRUMENT (S-ROM NUT TIGHTENER) IS BENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7506270 ↗