NA 75100858Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996121919), received between Dec 3, 2021 and Jun 17, 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.

• MalfunctionJun 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE TRIAL FEMORAL HEAD 36 L/+8 IS CRACKED AND WOULD NOT SECURE TO NECK TRIAL. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739110 ↗
• MalfunctionDec 3, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT A TRIAL FEMORAL HEAD 36 L/+8 HAS CRACKED AND BROKEN SECTIONS. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924302 ↗