InSitu Hip System 10-40-3650Recalls & reported problems
Nextstep Arthropedix, LLC · Acetabular Liner, Size 50 x 36mm ID, Neutral · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816127022739), received between Jul 10, 2025 and Jan 21, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Aseptic loosening1
- Limb Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
THIS EVENT IS ALSO DESCRIBED IN 3002498892-2025-00034 AND 3002498892-2025-00035. IT WAS REPORTED THAT THE FEMORAL STEM LOOSENED/SUBSIDED. THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED.
Patient problems: Aseptic loosening
MAUDE report 24134829 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FEMORAL PAIN AND THE FEMUR HAD TO BE REVISED.
Patient problems: Limb Pain
MAUDE report 22470828 ↗
Other Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented devices
- AcuMatch 142-32-27Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2 recalls0 reports
- Novation 140-36-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall8 reports
- G7 DEPTH GAUGE 110010717Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented54 reports
- Novation 140-32-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall2 reports
- Novation 142-32-61Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 140-36-54Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 142-28-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 148-32-51Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 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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