S-ROM 2576-05-021Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM MILLER SHELL SIZE 21 · Class 1
All models of S-ROM (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295145547), received between Aug 14, 2018 and Jul 26, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Material Twisted/Bent2
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Illegible Information1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2022Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A CASE THE SCREWS FROM AN SROM INSTRUMENT CAME OFF WHICH CAUSED THE INSTRUMENT TO SLIDE AND MAKE DIFFICULT TO REMOVE. WE ALSO NOTICED A MILLING DEVICE (WE DIDN'T USE IT BUT NOTICED IT) HAS MANY METAL FRAGMENTS ON IT AND THE MILLING AND NOTICEABLE BURRS OUT OF IT AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103889 ↗MalfunctionFeb 20, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; 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 9732486 ↗MalfunctionNov 16, 2018Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT IS CHIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8077635 ↗MalfunctionAug 14, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SROM MILLER SHELL SZ 21 BENT UPON EXTRACTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7781916 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page