R3 71365150Recalls & reported problems
Smith & Nephew, Inc. · R3 0 DEGREE 32MM INNER DIAMETER TRIAL ACETABULAR LINER 50MM OUTER DIAMETER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010599476), received between Jul 24, 2020 and Sep 17, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break4
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2021Crack; Crack
IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12488816 ↗MalfunctionAug 31, 2021Break; Break
IT WAS REPORTED THAT THE DEVICES WERE FOUND DEFECTIVE. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12400272 ↗MalfunctionAug 31, 2021Crack; Crack
IT WAS REPORTED THAT THE DEVICES WERE FOUND DEFECTIVE. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12399596 ↗MalfunctionNov 11, 2020Break; Break
IT WAS REPORTED THAT DURING INSPECTION THE LINER WAS FOUND CHIPPED AND BROKEN. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10826086 ↗MalfunctionNov 1, 2020Break; Break
IT WAS REPORTED THAT ONE OF THE LOCKING TABS BROKE OFF OF THE R3 0 DEGREES 32MM TRIAL 50MM. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10767824 ↗MalfunctionJul 24, 2020Break; Crack; Break; Crack
IT WAS REPORTED THAT THE R3 0DEG 32MM TRIAL 50MM WAS FOUND TO BE CRACKED. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10319569 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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