Minima S Instrument Set 9045.03.207Recalls & reported problems
Limacorporate SPA · Trial Modular Neck #7 · 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 08033390153928), received between Aug 22, 2024 and Aug 22, 2024 — 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.
MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem
DURING THE TEST REDUCTION OF A PRIMARY HIP ARTHROPLASTY PERFORMED ON (B)(6) 2024 , AN UNUSUAL NOISE WAS MADE AS IF THE LINER TRIAL AND HEAD TRIAL WERE RUBBING AGAINST EACH OTHER. WHEN DISLOCATING, IT WAS FOUND THAT THE MINIMA S TRIAL MODULAR NECK #7 (PRODUCT CODE 9045.03.207, LOT #17HM0AC) WAS INSERTED INTO THE BROACH TO THE POINT THAT THERE WAS NO GAP BETWEEN THEM. THIS SHORTENED THE TRIAL NECK LENGTH BY ABOUT 2 MM, MAKING IT DIFFICULT TO CONFIRM THE EXACT SOFT TISSUE BALANCE. BECAUSE THERE WAS NO GAP, THE NECK EXTRACTOR COULDN'T BE INSERTED, AND IT WAS MANAGED TO LIFT THE NECK TRIAL USING THE HOSPITAL'S K-WIRE AND INSERTING A ZUK REMOVAL HOOK TO REMOVE IT. THE SURGERY WAS PROLONGED FOR ABOUT 20 MINUTES DUE TO THE DIFFICULTIES ENCOUNTERED IN REMOVING THE NECK TRIAL. PATIENT IS A MALE, 74 YEARS OLD. IT WAS REPORTED HE'S A LARGE MALE WITH AMPLE MUSCLE MASS. EVENT HAPPENED IN JAPAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20036627 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
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- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
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- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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