R3 E0015292-1Recalls & reported problems
Smith & Nephew, Inc. · R3 CUP IMPACTOR · 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 00885556673928), received between Nov 16, 2020 and Nov 16, 2020 — 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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2020Break; Break
IT WAS REPORTED THAT THE HANDLE OF THE R3 CUP IMPACTOR BROKE OFF. IT IS UNKNOWN WHEN THIS EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10843613 ↗MalfunctionNov 16, 2020Break; Break
IT WAS REPORTED THAT THE HANDLE OF THE R3 CUP IMPACTOR BROKE OFF. IT IS UNKNOWN WHEN THIS EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10843280 ↗
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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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