EMPERION 71360920Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010535252), received between Dec 18, 2018 and Dec 19, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE TRIAL REMOVAL HANDLE BROKE WHILE EXTRACTING TRIAL STEM FROM PATIENT'S FEMUR. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849909 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REDAPT CASE, WHERE A TRIAL REMOVAL HANDLE BROKE DURING REGULAR USE-EXTRACTION OF FEMORAL STEM TRIAL. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR'S DEVICE., A HOOK HANDLE. PATIENT WAS ANESTHETIZED DURING THE DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502443 ↗
• InjuryAug 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN EMPERION TRIAL REMOVAL HANDLE BROKE DURING SURGERY, WHILE INSTRUMENT WAS INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285330 ↗
• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A TRIAL REMOVAL HANDLE BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155295 ↗
• InjuryJan 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, TRIAL REMOVAL HANDLE BROKE. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156932 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE TRIAL REMOVAL HANDLE BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114912 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT THE TRIAL REMOVAL HANDLE BROKE IN CASE. NO DELAY. SURGERY WAS COMPLETED WITH ORIGINAL DEVICE. PATIENT WAS NOT AFFECTED BY INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10763277 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT HANDLE BROKE WHILE BACK SLAPPING IN AN EFFORT TO REMOVE A REDAPT STEM. NO DELAY AND BACK-UP DEVICE WAS AVAILABLE. UNKNOWN IF ANY INJURY OR PATIENT IMPACT WAS INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727951 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT WHEN SURGEON WAS REMOVING STEM, HANDLE BROKE. ALL PIECES WERE RETRIEVED, NO DELAY, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173820 ↗

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