EMPERION 71360919Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010535245), received between Jun 4, 2018 and Jun 18, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, AN EMPERION SLEEVE/ STEM SEPARATOR BROKE DURING IMPACTION, INSIDE THE PATIENT. IT IS UNKNOWN IF THE SURGERY WAS RESUMED WITH A BACK UP DEVICE, NO DELAY WAS REPORTED. PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028643 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR, HANDLE BROKE WHILE IMPACTING. NO PIECES WERE LEFT IN THE PATIENT. NO DELAY TO CASE. NO S&N BACKUP AVAILABLE, SURGERY COMPLETED WITH A DIFFERENT NON-S&N DEVICE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839783 ↗
• MalfunctionJun 30, 2019Break; Break

  IT WAS REPORTED THAT A EDUCATIONAL LAB, DEVICE BROKE AT HANDLE DURING USE. NO INJURY TO ANYONE INVOLVED AND NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746855 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE IN HALF WHEN THE SEPARATOR WAS USED AND IMPACTED WITH A MALLET. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704299 ↗
• InjuryJun 4, 2018Break; Break

  TIP OF SCREW PORTION BROKE OFF. DR. PARCEL DETERMINED THAT IT WAS SAFER TO PATIENT TO LEAVE IT IMPLANTED IN THE BONE. BACKUP DEVICE WAS USED. NO DELAY TO PROCEDURE, DEVICE IS BEING RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7566007 ↗

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