R3 71935336Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556613627), received between Jul 13, 2020 and Mar 30, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED THAT, A PARABOLIC ACETABULAR REAMER DOME SZ 54MM 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 13945981 ↗
• MalfunctionJul 13, 2020Break; Break

  IT WAS REPORTED THAT AFTER THR PROCEDURE THE PARABOLIC ACETABULAR REAMER DOME SZ 54MM WAS FOUND TO BE CRACKED. NO DELAY, NO INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10268164 ↗