Biolox 18-3625Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154187331), received between May 4, 2026 and May 4, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 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.

• InjuryMay 4, 2026Degraded; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2026, A SALES REPRESENTATIVE RECEIVED AN EMAIL FROM REPORTING THAT A PATIENT HAD PRESENTED FOR MEDICAL CONSULTATION COMPLAINING OF PAIN IN THE RIGHT HIP, WHICH HAD UNDERGONE A RIGHT TOTAL HIP ARTHROPLASTY (THA) WITH A TRIDENT-ACCOLADE PROSTHESIS AT ANOTHER CLINIC IN 2019. X-RAYS SHOWED A LOSS OF SYMMETRY AND MISALIGNMENT OF THE HIP HEAD RELATIVE TO THE NECK. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THE STEM WAS BROKEN AT THE NECK. ON (B)(6) 2026, SURGICAL REVISION WAS PERFORMED, REVEALING A LOOSE CERAMIC HEAD, A STEM WITH AN AXIALLY BROKEN NECK, AND A MISSING FRAGMENT, ALL ASSOCIATED WITH SIGNIFICANT METALLOSIS AND SEVERE OSTEOLYSIS OF THE PROXIMAL FEMUR WHERE THE STEM WAS LOCATED. THE SURGEON WAS ABLE TO CLEAN THE AREA, REMOVE ALL DEBRIS, AND RECONSTRUCT THE HIP WITH A RECONSTRUCTION STEM AND REPLACE THE LINING. IN THE ATTACHMENT-INTAKE ARE PICTURES OF THE SURGERY REVISION.

  Patient problems: Insufficient Information; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 25072462 ↗