Restoration 6276-1-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540641236), received between May 9, 2023 and Apr 23, 2024 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2014 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND A RESTORATION MODULAR HIP SYSTEM. HE WAS REVISED ON (B)(6) 2022 DUE TO ALLEGED TRUNNIONOSIS.

  Patient problems: Insufficient Information

  MAUDE report 19163523 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: PATIENT HAD SECOND HIP REVISION PROCEDURE IN TWO MONTHS. HER THIRD HIP REVISION PROCEDURE IN TOTAL. ON THIS LATEST OCCASION, HER HIP PROSTHESIS HAD DISLOCATED SIMILAR TO THE PREVIOUS EVENT. SPECIFICALLY, SHE HAD A TRIDENT CONSTRAINED INSERT IN-SITU AND THE BIPOLAR HEAD HAD DISLOCATED FROM THE INSERT THAT IT HAD BEEN PRE-ASSEMBLED IN. THE INSERT WAS STILL IN THE ACETABULAR SHELL BUT THE BIPOLAR HEAD WAS COMPLETELY DISENGAGED FROM IT. THE BIPOLAR HEAD STILL HAD THE FEMORAL HEAD WITHIN IT WHICH ITSELF WAS STILL INTACT ON THE CONE BODY IMPLANT TRUNNION. UPDATE: AS PER INTAKE FORM, THE SURGEON EXPLANTED THE TRIDENT CONSTRAINED LINER, CERAMIC HEAD, TRIDENT CLUSTER SHELL, SCREWS AND THE CONE BODY.

  Patient problems: Joint Dislocation

  MAUDE report 16898750 ↗