Restoration 6276-4-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540641618), received between Oct 6, 2022 and Feb 15, 2024 — classified as 2 injuries.

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

• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. THE CONSTRAINED LINER, HEAD AND REST MOD PROXIMAL BODY WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD. REASON FOR REVISING WAS NOT GIVEN TO REP WHEN HOSPITAL STAFF WAS ASKED (NEITHER WERE ANY ALLEGATIONS MADE OR OBSERVED).

  Patient problems: Joint Dislocation

  MAUDE report 18717801 ↗
• InjuryOct 6, 2022Mechanical Problem; Mechanical Problem

  THIS PI IS FOR REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2022. WHILE PROVIDING INFORMATION FOR REVISION OF THE PATIENT'S LEFT HIP ON B)(6) 2022, REP PROVIDED A USAGE SHEET FROM A PRIOR REVISION ON B)(6) 2022. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE, BUT A STRYKER REP WAS PRESENT. PATIENT WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. SURGEON DECIDED THAT THE PATIENT DID NOT HAVE ENOUGH OFFSET. A RESTORATION MODULAR PROXIMAL BODY (IMPLANTED B)(6) 2020), AND A CONSTRAINED LINER AND FEMORAL HEAD (IMPLANTED B)(6) 2021) WERE REVISED. THE SHELL (IMPLANTED B)(6) 2020) WAS NOT REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15550338 ↗