Curved Cup ImpactorRecalls & reported problems
Limacorporate SPA · Curved Cup Impactor · Class 2
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 08033390104821), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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
- 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 2, 2026Mechanical Problem
DURING THE PROCEDURE ON (B)(6) 2026, THE CUP DID NOT PROPERLY ENGAGE WITH CURVED CUP IMPACTOR (PRODUCT CODE: 9095.11.550, LOT: 25BG084). THIS ISSUE CAUSED AN APPROXIMATE 20 MINUTE DELAY. THE INSTRUMENT HAD BEEN USED APPROXIMATELY 10 TIMES. THE SURGERY WAS COMPLETED USING THE STRAIGHT CUP IMPACTOR WITHOUT FURTHER COMPLICATIONS. THERE WAS NO IMPACT ON THE PATIENT. THE INSTRUMENT SET HAD BEEN CHECKED BY THE SCRUB NURSE AND WAS USED APPROPRIATELY THROUGHOUT THE PROCEDURE. THE SURGEON IS AN EXPERIENCED USER OF LIMA DEVICES. THE PROCEDURE PERFORMED WAS A PRIMARY THA. EVENT OCCURRED IN ITALY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24763578 ↗
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- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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