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S-ROM 2576-30-004Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM NECK TRIAL 30 STD +4 LAT · Class 1

All models of S-ROM (92)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295147046), received between Sep 14, 2017 and Sep 15, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Device problems

  • Device-Device Incompatibility3
  • Material Deformation3
  • Material Twisted/Bent2
  • Appropriate Device Problem Term/Code Not Available1
  • Misconnection1
  • Naturally Worn1
  • Scratched Material1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Clinical Signs, Symptoms or Conditions2
  • No Information1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 15, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

    IT WAS REPORTED THAT THE THREADS OF NECK TRIAL D257630004 ARE STRIPPED AND IT WILL NOT SECURELY ATTACH TO A STEM TRIAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17754286 ↗
  • MalfunctionOct 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE DEVICE NECK WAS NOT LOCKING ONTO THE STEM TRIAL. THERE WAS SURGICAL DELAY FOR A FEW MINUTES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15665855 ↗
  • MalfunctionJul 31, 2019Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Deformation; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE THREAD ON THE TRIAL SROM NECK WAS STRIPPED AND THEY WON'T TIGHTEN TO THE STEM TRIAL. THE HEAD BALL TRIAL 28+3MM HAS SCRATCHED. NO SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8846939 ↗
  • MalfunctionMay 31, 2019Material Deformation; Material Twisted/Bent; Scratched Material; Material Deformation; Material Twisted/Bent; Scratched Material

    IT WAS REPORTED THAT THE TRIAL NECK IS WORN AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8659589 ↗
  • MalfunctionMay 20, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

    IT WAS REPORTED THAT THE SROM NECK TRIAL WOULD NOT ENGAGE TO STEM TRIAL. ENDED UP USING ANOTHER NECK LENGTH. ANYHOW PRODUCT WILL BE RETURNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8624669 ↗
  • MalfunctionSep 14, 2017Misconnection; Misconnection

    IT WAS REPORTED THAT THE STEM BODY TRIAL STRIPPED AND WON'T CONNECT TO THE NECK TRIALS AND NEED TO BE REPLACED.

    Patient problems: No Information

    MAUDE report 6864285 ↗

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Sources and updates

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