NA 71352117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010619563), received between Nov 30, 2017 and Jul 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Corroded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072417); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2020Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SMF STEM WAS REVISED DUE TO CORROSION AT NECK JUNCTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10254446 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY. THIS WAS A REVISION OF A RIGHT ANTEVERTED MODULAR NECK SMF. SURGEON WANTED TO FIX THE PROBLEM BY SWITCHING THE ANTEVERTED NECK FOR A RETROVERTED NECK BUT SINCE THIS WAS NO LONGER AN OPTION IN SURGEON'S EXPECTED TIMEFRAME HE HAD TO REMOVE THE WELL FIXED SMF STEM, AND GIVE THIS PATIENT A REVISION HIP STEM.

  Patient problems: Failure of Implant; Joint Disorder

  MAUDE report 7069996 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072417. One submission often covers many models, so check the product and lot details in each record.

• Z-0946-2017 · Nov 15, 2016 · Terminated
  Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have f