NA 282.239Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982178268), received between Aug 12, 2020 and Aug 12, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT REMOVAL OF DYNAMIC HELICAL HIP SYSTEM (DHHS) FOLLOWED BY CONVERSION OF TOTAL HIP REPLACEMENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DHHS SYSTEM ON AN UNKNOWN DATE. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS REPORT IS FOR A HELIX BLADE. (B)(4) IS LINKED TO THIS COMPLAINT.

  Patient problems: Injury

  MAUDE report 10395301 ↗