Restoration 1235-2-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540638731), received between Jul 1, 2019 and Apr 10, 2020 — 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.

• InjuryApr 10, 2020Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  STEM SUBSIDENCE OF 13 MM OF SECUR-FIT ADVANCED STEM FOR CLINICAL STUDY PATIENT. UPDATE 15/JANUARY/2020 WG: AS REPORTED: "UPON REVIEW OF THE SUBJECT'S SIX-WEEK POSTOPERATIVE X-RAYS, IT WAS NOTED THAT THE STEM MOVED 13MM. THE EVENT WAS NOTED AS FEMORAL COMPONENT SUBSIDENCE, AND CONSIDERED BY THE STUDY INVESTIGATOR TO BE DEVICE RELATED AND SERIOUS. THIS SUBSIDENCE RESULTED IN A REVISION OF THE FEMORAL BEARING HEAD ON (B)(6) 2014, AND WAS CONSIDERED RESOLVED AT THAT TIME." LEFT HIP. UPDATE 13 MARCH 2020 BASED ON MEDICAL REVIEW: "THE X-RAY COPIES OF THE POSTOPERATIVE FILMS FROM THE PRIMARY SURGERY SHOWED A SUBSIDED STEM AND A SOMEWHAT OVERSIZED AND NOT FULLY SEATED CUP. THE STEM LOOKED UNDERSIZED. THE SUBSIDENCE LED TO LIMB LENGTH DISCREPANCY AND ULTIMATELY TO FEMORAL HEAD REVISION TO IMPROVE THE LENGTH DISCREPANCY.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9948399 ↗
• InjuryJul 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "LEFT THA REVISION DUE TO DISLOCATION. PATIENT EXPERIENCED DISLOCATION. DURING THE ATTEMPT TO REDUCE HER HIP, THE FORCE BEING APPLIED PRIED THE ADM INSERT OFF OF THE 28MM HEAD". SPOKE TO REP. THE RESTORATION ADM INSERT DISASSOCIATED OUT OF THE RESTORATION ADM SHELL. PATIENT WENT TO ER WHERE A CLOSED REDUCTION WAS ATTEMPTED. DURING THE REDUCTION THE HEAD DISLOCATED OUT OF THE LINER AND THE PATIENT WAS REVISED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8750668 ↗