Viant Medical, LLC 510912Recalls & reported problems
Viant Medical · Metal Handle Offset Cup Impactor · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840096401011), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Failure to Disconnect1
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Mechanical Problem; Failure to Disconnect; Connection Problem; Mechanical Jam; Mechanical Problem; Failure to Disconnect; Connection Problem; Mechanical Jam
IT WAS REPORTED DURING THE TOTAL HIP ARTHROPLASTY (THA) CUP PLACEMENT, THE CUP COULD NOT BE REMOVED FROM THE OFFSET IMPACTOR AND COULD NOT BE IMPLANTED INTO THE ACETABULUM. THE PHYSICIAN THEN REAMED UPWARD WITH A 46MM REAMER AND IMPLANTED A 46MM CUP USING A STRAIGHT IMPACTOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT AND MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS DELAYED 60 MINUTES DUE TO THE INCIDENT. THE USER FACILITY INDICATED THE PHYSICIAN HAD TIGHTENED THE CUP TOO HARD WHEN ATTACHING IT AND THE OFFSET IMPACTOR WAS NOT DAMAGED. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903186 ↗
Other Impactor devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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