NA 71332800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010385338), received between Feb 25, 2019 and May 16, 2019 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionMay 16, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY, IT WAS L FOUND THAT THE LOT OF PRODUCT AND THE LOT OF PACKAGE WAS DIFFERENT, AND HOSPITAL REFUSED TO USE. A DELAY GREATER THAN TWO HOURS WAS REPORTED. NO MORE INFORMATION AVAILABLE YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616007 ↗
• InjuryFeb 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S BALL HEAD IS BROKEN. A REVISION SURGERY WAS PERFORMED ON THE PATIENT TO CORRECT THE ADVERSE EVENT. BROKEN DEVICE WAS REPLACED WITH A SMITH & NEPHEW'S IMPLANT.

  Patient problems: Injury

  MAUDE report 8368341 ↗