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InSitu Hip System 10-20-3604Recalls & reported problems

Nextstep Arthropedix, LLC · Femoral Head, 36mm, +10mm, CoCr Skirted · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816127022357), received between May 18, 2018 and May 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 18, 2018Loose or Intermittent Connection

    SURGEON REPLACED ACETABULAR LINER AND FEMORAL HEAD TO IMPROVE STABILITY AND OVERALL LENGTH. DR. HAD OBSERVED THAT HIP IMPLANTS WERE LOOSE.

    Patient problems: Failure of Implant

    MAUDE report 7526135 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices →

Sources and updates

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