NA 52855-34Recalls & reported problems
Smith & Nephew, Inc. · Impactor Cup Insert - Thread 3/8 - 16 UNC · Class 2
Data updated Oct 13, 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 00885556909416), received between Apr 23, 2025 and Jan 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Twisted/Bent1
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.
MalfunctionJan 5, 2026Fracture
IT WAS REPORTED THAT DURING A THA, THE TIP OF A IMPACTOR CUP INSERT TRD 3/8 - 16 UNC HAD A PIECE OF METAL BREAK OFF WHILE TRYING TO MOVE THE CUP. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960402 ↗MalfunctionApr 23, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT, DURING THE SET UP FOR A THR SURGERY, IT WAS NOTICED THAT FIVE (5) IMPACTOR CUP INSERT TRD 3/8 - 16 UNC ARE BENT. X-RAY WAS USED TO POSITION THE CUP INSTEAD OF NAVIGATION SYSTEM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21888715 ↗
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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 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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