DURALOC 2220-36-554Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295102663), received between Aug 17, 2017 and Sep 14, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUP THREADS WERE MISSING AND THE APG SIZER GUIDE HAD DEEP SCRATCHES, GROOVES IN SURFACE. BOTH WERE FOUND WHEN THE SETS WERE RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470955 ↗
• MalfunctionSep 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL RING CAME OFF OF TRIAL DURING LINER TRIALING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447161 ↗
• MalfunctionJun 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CENTER HOLE OF LINER IS MISSING ALONG WITH THE ALLIGATOR CLIP. THEREFORE, LINER IS UNUSABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7624637 ↗
• MalfunctionMar 22, 2018Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER IS MISSING A CENTER SCREW. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361430 ↗
• MalfunctionJan 12, 2018Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL DISCOVERED BROKEN WHEN RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185419 ↗
• MalfunctionSep 13, 2017Break; Break

  IT WAS REPORTED THAT LINER TRIAL BROKE DURING TRIALING AND ALL PIECES WERE RECOVERED. SEPTEMBER 12, 2017 - EVALUATION OF THE RETURNED TRIAL LINER FOUND THE SCREW BROKE OUT OF THE SHELL COMPONENT WITH MATERIAL AROUND IT.

  Patient problems: No Information

  MAUDE report 6861943 ↗
• MalfunctionAug 17, 2017Break; Break

  IT WAS REPORTED THAT THE SCREWS ARE BROKEN OUT OF TRIAL. SURGEONS ARE COMPLAINING.

  Patient problems: No Information

  MAUDE report 6801446 ↗