Restoration 1235-2-542Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540638779), received between May 14, 2019 and Sep 4, 2019 — 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.

• InjurySep 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING EVENT WAS REPORTED : "INTRAPROSTHETIC DISLOCATION BETWEEN 28 MM METAL HEAD AND PE 54/28 INSERT. EQUIPMENT IMPLANTED IN (B)(6) 2017. WEAR OF THE METAL HEAD. UPDATE 05/JUNE/2010 WG: AS REPORTED IN ADVERSE CONSEQUENCES DETAILS: SENSATION OF DISLOCATION CLINICAL + METALLOSIS PER OP BY HEAD WEAR. OBLIGATION TO CHANGE METAL BACK : REMOVAL AND RETURN.

  Patient problems: Injury; Joint Dislocation; Reaction

  MAUDE report 8959760 ↗
• InjuryMay 14, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. THE SURGEON REPORTED THAT THE SHELL WAS "A LITTLE VERTICAL". A PRE-REVISION X-RAY PROVIDED BY THE REP ALSO CITES A LIMB LENGTH DISCREPANCY OF 7MM. INTRA-OPERATIVELY, THE SHELL AND STEM WERE NOTED TO BE WELL-FIXED. REP ALSO PROVIDED PRIMARY AND REVISION IMPLANT SHEETS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 8609242 ↗