S-ROM 2576-11-102Recalls & reported problems
Depuy (Ireland) · S-ROM DISTAL STEM TRIAL, LONG - NEUTRAL SIZE 11 · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295146070), received between Nov 30, 2018 and Jan 28, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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
- Delivered as Unsterile Product1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN ORGANIZING THE INSTRUMENTS AFTER THEY WERE CLEANED BY SPD IT WAS DISCOVERED THAT THE TWO SROM INSTRUMENTS WERE STUCK TOGETHER. THIS DID NOT IMPACT THE CASE IN ANY WAY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13384779 ↗MalfunctionNov 30, 2018Delivered as Unsterile Product; Delivered as Unsterile Product
REPORTED A LARGE AMOUNT OF YELLOW DYE COMING OFF THE SROM LONG STEM TRIALS (INSTRUMENTS), IN THE LONG; XL 11X 16 SIZE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8120280 ↗
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.
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