InSitu Hip System 10-11-0006Recalls & reported problems
Nextstep Arthropedix, LLC · Femoral Stem, Size 6, Lateralized · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816127022135), received between Dec 22, 2017 and Sep 13, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (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.
Most reported problems
Device problems
- Device Slipped1
- Fracture1
Patient problems
- No Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2019Fracture
DURING THE PRIMARY HIP ARTHROPLASTY THE SURGEON BELIEVED HE IDENTIFIED AN INTRA-OPERATIVE FRACTURE AFTER INSERTING THE STEM. HE REMOVED THE STEM, UTILIZED CIRCLAGE CABLE, AND REINSERTED THE STEM. UPON REINSERTING THE STEM THE FRACTURE WAS MORE APPARENT AND THE STEM SUBSIDED. THE STEM WAS REMOVED AGAIN AND A COMPETITOR'S STEM WAS IMPLANTED.
Patient problems: No Information
MAUDE report 9040488 ↗InjuryDec 22, 2017Device Slipped
PATIENT PRESENTED WITH THIGH PAIN CONSISTENTLY AFTER PRIMARY SURGERY. WAS FOLLOWED AND DETERMINED BY SURGEON THAT THE STEM WAS LOOSE UPON IMPLANTATION. STEM WAS REMOVED, CONFIRMED AS LOOSE AND REPLACED WITH LONGER STEM ON (B)(6) 2017.
Patient problems: Pain
MAUDE report 7144552 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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