R3 71362023Recalls & reported problems
Smith & Nephew, Inc. · R3 0 DEGREE 40MM INNER DIAMETER PERMANENT TRIAL LINER 58MM OUTER DIAMETER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556111369), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2020Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE THR, THE TAB ON THE LINER TRIAL WAS BROKE INSIDE THE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A SURGICAL DELAY. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Foreign Body In Patient
MAUDE report 10382272 ↗
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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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