TANDEM 71363042Recalls & reported problems
Smith & Nephew, Inc. · TANDEM TRIAL SHELL 42MM · Class 1
All models of TANDEM (58)
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 03596010481559), received between Sep 30, 2020 and Mar 22, 2022 — classified as 2 malfunctions.
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
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2022Break; Break
IT WAS REPORTED THAT A TANDEM TRIAL SHELL 42MM WAS FOUND TO BE CHIPPING. IT CAN NOT BE USED IN SURGERY SINCE THE PLASTIC IS CHIPPING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13848825 ↗MalfunctionSep 30, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING EFIP INSPECTION IT WAS FOUND NO THREADS ON THE TRIAL SHELL. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10609470 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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