EMPERION 71364036Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010569646), received between Apr 6, 2021 and Apr 25, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K113789); 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 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.

• MalfunctionApr 25, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING THE SURGERY THE EMP SLV REMOVAL TOOL WAS BEING PROPERLY USED BUT WHEN IMPACTED, THE SURFACE BECAME DISASSOCIATED FROM THE HANDLE (OUTSIDE THE PATIENT). THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192632 ↗
• MalfunctionJan 26, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT THE WELD BROKE ON THE EMP SLAV REMOVAL TOOL HANDLE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353741 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE EMPERION SLV REMOVAL TOOL WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113789. One submission often covers many models, so check the product and lot details in each record.

• Z-0945-2017 · Nov 15, 2016 · Terminated
  Modular SMF(TM) 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