S-ROM 53-2860Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM LINER TURNER · Class 1
All models of S-ROM (92)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295171652), received between Feb 7, 2019 and Oct 19, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- No Consequences Or Impact To Patient3
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2020Break; Break
SROM CUP LINER TURNER BROKE IN HALF. NO SURGICAL DELAYS OR REPORTED PATIENT CONSEQUENCES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10700469 ↗MalfunctionMar 30, 2020Break; Break
IT WAS REPORTED THAT THE SROM LINER TURNER BROKE UPON TIGHTENING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9897904 ↗MalfunctionFeb 7, 2019Break; Break
IT WAS REPORTED THAT THE SROM LINER INSERTER WAS BROKEN. THIS WAS DISCOVERED IN STERILE PROCESSING AND THE DEVICE WAS NOT USED IN A CASE. THE TINES OF THE INSERTER BROKE; IT BROKE INTO TWO (2) PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317505 ↗
Other CLAMP devices
- ATTUNE 2544-00-001Depuy (Ireland) · CLAMP144 reports
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB461RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB738RAesculap AG · CLAMP1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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