Restoration 1235-2-642Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540638878), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2021Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PRIOR TO REVISION, THE PATIENT PRESENTED TO THE E.R. FOR AN UNSUCCESSFUL CLOSED REDUCTION AND THE DECISION WAS MADE TO REVISE THE HIP. INTRA-OPERATIVELY, THE ADM/ MDM POLY WAS OBSERVED TO BE DISLOCATED FROM THE ADM SHELL, AND DISSOCIATED FROM THE FEMORAL HEAD. AS THE SURGEON WANTED TO GO WITH A SMALLER INSERT/ HEAD OPTION, THE DECISION WAS MADE TO REVISE THE SHELL, HEAD AND LINER.

  Patient problems: Joint Dislocation

  MAUDE report 11340307 ↗