Consensus® Hip System 1015-0-4850Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844588002373), received between Aug 23, 2019 and Aug 23, 2019 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

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

• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THIS PATIENT PRESENTED AT THE (B)(6) EMERGENCY DEPT. AFTER SUSTAINING A "HARD FALL". CLINICAL EVALUATION AND X-RAY FINDINGS YIELDED A DIAGNOSIS OF A BIPOLAR HIP REPLACEMENT WHICH WAS REACHED AND THE DECISION WAS MADE BY THE EMERGENCY ROOM PHYSICIAN TO ATTEMPT A REDUCTION OF THE DISLOCATION. AT SOME POINT DURING THE ATTEMPTED REDUCTION, DISASSOCIATION OF THE 28MM FEMORAL HEAD FROM THE BI-POLAR INSERT OCCURRED. THE PATIENT WAS THEN ADMITTED TO (B)(6) M.D. FOR FURTHER EVALUATION AND TREATMENT AT (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8927045 ↗