Modulus Hip System Neck ExtractorRecalls & reported problems
Limacorporate SPA · Neck Extractor · Class 2
Data updated Oct 16, 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 08033390030816), received between Jan 13, 2025 and Jan 13, 2025 — 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 16, 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.
MalfunctionJan 13, 2025Break; Break
DURING A HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO SEPTIC ARTHRITIS, THE REPLACEMENT OF THE NECK AND STEM WAS SCHEDULED. AFTER REMOVING THE SAFETY SCREW FROM THE MODULUS NECK S-125 (PRODUCT CODE 7590.15.030, LOT # UNKNOWN) AND THE MODULUS MODULAR STEM Ø24 MM (PRODUCT CODE 4310.15.120, LOT #0602329), THE SURGEON ATTEMPTED TO REMOVE THE NECK USING THE MODULUS NECK EXTRACTOR (PRODUCT CODE 9043.10.360, LOT #1510864), BUT THE THREADED TIP OF EXTRACTOR BROKE. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE NECK AS THE BROKEN PART REMAINED IN THE NECK. ONLY THE LINER HAS BEEN REPLACED TO COMPLETE THE SURGERY, AND THE FEMORAL STEM AND NECK HAVE BEEN LEFT IN SITU. ACCORDING TO THE RECEIVED INFORMATION, THE SURGERY WAS PERFORMED AS PER SURGICAL TECHNIQUE, THREADING THE EXTRACTOR BY HAND. DUE TO THE EVENT, THE SURGICAL TIME WAS PROLONGED FOR 5-6 MINUTES. EVENT HAPPENED IN JAPAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21136106 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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