R3 71360556Recalls & reported problems
Smith & Nephew, Inc. · R3 0 DEGREE 28MM INNER DIAMETER TRIAL ACETABULAR LINER 56MM OUTER DIAMETER · Class 1
Data updated Oct 16, 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 03596010598899), received between Sep 3, 2021 and Sep 9, 2021 — classified as 2 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 16, 2026.
Most reported problems
Device problems
- Break2
- Scratched Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2021Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE R3 0DEG 28MM TRIAL 50MM, THE R3 0DEG 28MM TRIAL 52MM, THE R3 0DEG 28MM TRIAL 54MM, THE R3 0DEG 28MM TRIAL 56MM, AND THE R3 0DEG 28MM TRIAL 58MM WERE FOUND TO BE SCRATCHED, AND HAD BROKEN LOCKING TABS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450323 ↗MalfunctionSep 3, 2021Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT. A R3 0DEG 28MM TRIAL 50MM, R3 0DEG 28MM TRIAL 52MM, R3 0DEG 28MM TRIAL 54MM, R3 0DEG 28MM TRIAL 56MM AND A R3 0DEG 28MM TRIAL 58MM ARE SCRATCHED AND HAS BROKEN LOCKING TABS. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12425081 ↗
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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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