NA 75100843Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996121766), received between Sep 17, 2021 and Sep 28, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TABS OF AN UNIDENTIFIED TRIAL FEMORAL HEAD BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL OFF INSIDE OF THE PATIENT. IT IS ALSO UNKNOWN HOW SURGERY WAS COMPLETED AND FOR LONG IT WAS PROLONGED, IF ANY. PATIENT WAS NOT STATED TO BE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498400 ↗
• InjurySep 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, WHEN REMOVING THE FEMUR FROM THE ACETABULAR COMPONENT (AFTER TRIALING), ONE PIECE OF THE FOUR RECESS THAT CLAMP THE UNIDENTIFIED TRIAL FEMORAL HEAD ONTO THE FEMORAL NECK BROKE OFF. THE PIECE WAS RETRIEVED. ALL PIECES WERE REMOVED FROM PATIENT WITH TWEEZERS. SURGERY WAS CONTINUED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375405 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488098 ↗