Restoration 504-02-62E-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327012453), received between May 20, 2019 and Jun 27, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled

  UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANTS WERE LOOSE IN PACKAGING. THE IMPLANTS HAVE BEEN SHIPPED TO THE (B)(6) LAB. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8738798 ↗
• MalfunctionJun 24, 2019Packaging Problem; Packaging Problem

  UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANTS WERE LOOSE IN PACKAGING. IT HAS BEEN SHIPPED TO THE DECON LAB. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8728597 ↗
• MalfunctionJun 11, 2019Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  PRIMARY PROCEDURE, LEFT THA. IT WAS REPORTED THAT WHEN THE SIZE 60 SHELL WAS OPENED, THE SHELL HAD COME OFF THE POST THAT HOLDS IT IN PLACE IN THE PACKAGING, AND SOME OF THE OUTER BEADING WAS ABRADED OFF THE SHELL. A SIZE 62 SHELL WAS OPENED AND WAS ALSO LOOSE IN THE PACKAGING WITH SOME OF THE OUTER BEADING REMOVED. THE SURGEON DECIDED TO GO WITH A REVISION SHELL WHICH WAS AVAILABLE IN THE O.R. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN A MINUTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687101 ↗
• InjuryMay 20, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A LOOSE SHELL. REPORTED PATIENT FACTOR: SCLEROTIC BONE. THE SHELL, LINER AND HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE HEAD OR LINER, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8624116 ↗