InSitu Hip System 10-40-3654Recalls & reported problems
Nextstep Arthropedix, LLC · Acetabular Liner, Size 54/56 x 36mm ID , Neutral · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816127022753), received between Dec 22, 2017 and Jan 9, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Joint Dislocation1
- Unequal Limb Length1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
THIS EVENT IS ALSO DESCRIBED IN 3002498892-2025-00031 AND 3002498892-2025-00032. IT WAS REPORTED THAT THE FEMORAL STEM SUBSIDED. THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED.
Patient problems: Unequal Limb Length
MAUDE report 24028719 ↗MalfunctionDec 17, 2020Unstable
PATIENT'S HIP WAS REVISED TO TREAT INSTABILITY/DISLOCATION THAT RESULTED FROM RIGOROUS ACTIVITY. THE FEMORAL HEAD WAS REPLACED WITH A HIGHER OFFSET VERSION AND THE NEUTRAL LINER WAS REPLACED WITH A HOODED LINER.
Patient problems: Joint Dislocation
MAUDE report 11028076 ↗InjuryDec 22, 2017Insufficient Device Problem Information
SURGEON PERFORMED A REVISION SURGERY. HE LEFT THE WELL FIXED STEM AND CUP AND REPLACED THE LINER AND HEAD. REVISION SURGERY WAS PERFORMED DUE TO INFECTION PROBLEM.
Patient problems: Unspecified Infection
MAUDE report 7144328 ↗
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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