Restoration 504-02-60D-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327012422), received between Jun 11, 2019 and Jun 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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.

• MalfunctionJun 11, 2019Material Deformation; Packaging Problem; Component Misassembled; Material Deformation; Packaging Problem; Component Misassembled

  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 OPERATING ROOM SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN A MINUTE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8687104 ↗