Restoration 1235-2-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540638724), received between Aug 15, 2018 and Aug 19, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A (CUSTOMER) REPORTED THAT: "DURING IMPLANTATION, THE OPERATORS NOTICED THAT THERE WASN'T THE USUAL MARK ON THE ACETABULUM (A SMALL NOTCH ALLOWING IT TO BE CORRECTLY ORIENTED ON THE IMPLANT HOLDER). IN THE ABSENCE OF OTHER ABNORMAL ELEMENTS, THE SURGEON DECIDED TO IMPLANT THE DEVICE ANYWAY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8905772 ↗
• InjuryAug 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "RIGHT HIP REVISION DUE TO INTRAPROSTHETIC DISLOCATION¿EXPLANTED A 50/28 ADM X3 POLY". UPDATE 19-JUL-2018: AS REPORTED BY REP: "HEAD WAS DISLOCATED FROM POLY AND ALSO POLY WAS DISLOCATED FROM CUP".

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7785516 ↗