MODULUS Femoral Stem 9043.10.310Recalls & reported problems
Limacorporate SPA · Manual 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 08033390024730), received between May 14, 2026 and May 14, 2026 — classified as 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionMay 14, 2026Break
ON (B)(6) 2026 DURING A PLANNED HIP REVISION SURGERY, INVOLVING ONE TT WITH MODULUS R, THE MANUAL IMPACTOR (PRODUCT CODE:9043.10.310 - LOT: UNKNOWN) FRACTURED DURING TRIALING WITH A SIZE 23 TRIAL STEM, AFTER FEMORAL PREPARATION WITH REAMERS. THE EXTRACTION OF THE TRIAL STEM WAS DIFFICULT. THE PROCEDURE WAS COMPLETED BY IMPLANTING A REVISION STEM, AVAILABLE ON CONSIGNMENT AT THE HOSPITAL. EVENT OCCURRED IN ITALY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25169993 ↗
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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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