R3 71935334Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556613603), received between Mar 30, 2022 and Aug 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PARABOLIC ACETABULAR REAMER DOME SZ 52MM BROKE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287606 ↗
• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED THAT, A PARABOLIC ACETABULAR REAMER DOME SZ 52MM IS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO THE SURGERY AND IF THERE WAS ANY DELAY AS A CONSEQUENCE OF THIS ISSUE. HOWEVER, A S+N BACK UP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13946021 ↗