S-ROM 53-6322Recalls & reported problems
Depuy (Ireland) · S-ROM HIP STEM TRIAL BODY 22mm · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295172826), received between Jun 1, 2018 and Jun 1, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2018Bent; Scratched Material; Bent; Scratched Material
NEW REP AT (B)(6) MEDICAL CENTER. WENT THROUGH INSTRUMENT INVENTORY ON (B)(6) 2018, AND NOTICED A FEW INSTRUMENTS THAT WERE IN AN UNACCEPTABLE CONDITION. THIS INSTRUMENT WAS NOT USED DURING A SURGERY AND NO STAFF MEMBER HAD MENTIONED THE DAMAGE. THIS IS A SROM 22 PROXIMAL BODY (COLOR: BLACK). THE GROVES WHERE THE NECK TRIAL SITS ARE DAMAGED ( BENT, CHIPPED). ASKING THAT THESE ARE REPLACED AND SHIPPED TO: (B)(6). THE DAMAGED INSTRUMENTS WILL BE RETURNED TO (B)(4). LOT CODE: SS0199. ON THE COMPLAIN TOOL; YOU ARE UNABLE TO ADD THE LOT CODE. THE PRODUCT WON'T ADD/UPLOAD WHEN THE LOT IS ALSO TYPED. PATIENT CONSEQUENCE? NO. PATIENT CONSEQUENCE DESCRIPTION: NOT USED IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7560316 ↗
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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