S-ROM 2576-36-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295147084), received between Jan 29, 2018 and Dec 8, 2022 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON THE 36+12 SROM NECK TRIAL, THE SCREW-IN PIECE THAT CONNECTS TO THE DISTAL STEM STRIPPED. ALSO, THE 36+0 HEAD TRIAL WAS VERY LOOSE ON THE TRIAL NECK TRUNNION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940614 ↗
• MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIAL WOULD NOT SCREW IN TO THE STEM TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15151985 ↗
• MalfunctionJul 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH THE NECK AND THE STEM WILL NOT LOCK TIGHTEN DOWN TOGETHER. THE NECK DOESN¿T WORK ON ANY OTHER STEM TRIAL AND THE STEM TRIAL WILL NOT TIGHTEN TO ANY NECK. BOTH NEED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14985709 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK SEGMENT WOULD NOT STAY LOCKED DOWN TO THE STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554639 ↗
• MalfunctionMar 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIALS NO LONGER ATTACH TO THE STEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570702 ↗
• MalfunctionJul 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 36+12 S-ROM NECK SEGMENT NOT LOCKING DOWN ONTO THE TRIAL STEM. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10339863 ↗
• MalfunctionMay 18, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SROM 1 NECK TRIAL 36+12 PART #257636012. NO LOT # VISIBLE. SURGICAL CHECKED TO MAKE SURE NECK TRIAL WOULD LOCK ON TO TRIAL SYSTEM BUT PRIOR TO CASE STARTED + IT WOULD NOT OPEN SPACER SET. NO IMPACT OR DELAY TO PATIENT. WHEN TIGHTEN PER TECHNIQUE NECK TRIAL WILL NOT LOCK TIGHTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067266 ↗
• MalfunctionApr 23, 2020Material Twisted/Bent; Naturally Worn; Illegible Information; Material Twisted/Bent; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THESE INSTRUMENTS HAVE EXCESSIVE WEAR AND ARE DIFFICULT TO READ. REP INDICATED "THAT THEY NEED TO BE REPLACED". NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992125 ↗
• MalfunctionFeb 19, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information; Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENT WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729055 ↗
• MalfunctionSep 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PROXIMAL NECK WON'T SECURELY TIGHTEN ON ANY STEM TRIALS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9056435 ↗
• MalfunctionMar 29, 2019Device-Device Incompatibility; Material Deformation; Scratched Material; Device-Device Incompatibility; Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE 18X13 STEM TRIAL AND 18X13 36+12 NECK TRIAL DO NOT ENGAGE PROPERLY WHEN THREADED TOGETHER. BOTH NEED REPLACED. SURGICAL DELAY FOR 3 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 8465460 ↗
• MalfunctionJan 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SLEEVE INTRODUCER WILL NOT STAY LOCKED WHEN THE HANDLE IS BEING EXTRACTED. ALSO, 18X13 STEM TRIAL AND 36+12 NECK HAS BAD THREADS.

  Patient problems: Not Applicable

  MAUDE report 8285760 ↗
• MalfunctionJul 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NECK SEGMENT NO LONGER LOCKS INTO DISTAL STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7670368 ↗
• MalfunctionJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NECK SEGMENT NO LONGER LOCKS TO DISTAL STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669537 ↗
• MalfunctionJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NECK SEGMENT NO LONGER LOCKS TO DISTAL STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669453 ↗
• MalfunctionJul 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NECK SEGMENT NO LONGER WILL LOCK TO DISTAL STEM TRIAL WITHOUT LOOSENING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669416 ↗
• MalfunctionMay 14, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT WHEN TRIALING NECK SEGMENTS, IT WAS DISCOVERED THAT THE 36+12 NECK TRIAL WOULD NOT TIGHTLY SCREW DOWN ON THE TRIAL STEM. IT APPEARS THAT THE THREADS MAY BE STRIPPED. WE OPENED BOTH SETS AND BOTH NECK TRIALS WERE AFFECTED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7510061 ↗
• MalfunctionMay 14, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT WHEN TRIALING NECK SEGMENTS, IT WAS DISCOVERED THAT THE 36+12 NECK TRIAL WOULD NOT TIGHTLY SCREW DOWN ON THE TRIAL STEM. IT APPEARS THAT THE THREADS MAY BE STRIPPED. WE OPENED BOTH SETS AND BOTH NECK TRIALS WERE AFFECTED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7510050 ↗
• MalfunctionJan 29, 2018Break; Break

  IT WAS REPORTED THAT THE SROM NECK TRIAL WAS DAMAGED. SURGICAL DELAY OF 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7225252 ↗