EXETER 0580-1-444Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540153333), received between Nov 19, 2019 and Jul 28, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  The following information was provided: Stryker THA revised due to periprosthetic fracture, original stem head and liner removed, replaced with Exeter Long Stem (44 No 3 260), MDM liner (E) and 28 +4 head.

  Patient problems: Ambulation or Postural Difficulties; Periprosthetic fracture

  MAUDE report 50057667 ↗
• MalfunctionJan 19, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING THE PRIMARY TOTAL HIP ARTHROPLASTY, A DEFECT IN PRODUCTS 0580-1-444 LOT G7986847 (TWO IDENTICAL PRODUCTS) WAS DETECTED. THE DISTAL END OF THE PIN IS THICKER THAN IT SHOULD BE. UNABLE TO PUT ON THE CENTRALIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11192107 ↗
• MalfunctionJan 19, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING THE PRIMARY TOTAL HIP ARTHROPLASTY, A DEFECT IN PRODUCTS 0580-1-444 LOT G7986847 (TWO IDENTICAL PRODUCTS) WAS DETECTED. THE DISTAL END OF THE PIN IS THICKER THAN IT SHOULD BE. UNABLE TO PUT ON THE CENTRALIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11191943 ↗
• MalfunctionDec 22, 2020Misassembled; Defective Device; Misassembled; Defective Device

  DURING HIP ARTHROPLASTY SURGERY, AN EXETER 44-4 STEM WAS FOUND TO BE DEFECTIVE (REF (B)(6), LOT G7681256). THE DISTAL END OF THE STEM WAS THICKER THAN IT SHOULD BE. THE CENTRALIZER DOES NOT FIT ON THE LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11054304 ↗
• InjuryNov 27, 2019Unstable; Unstable

  SECOND STAGE REVISION OF TRITANIUM PRIMARY CLUSTER CUP WITH ADM & EXETER. ALL COMPONENTS REVISED DUE TO INSTABILITY & HEAD/ADM INSERT DISASSOCIATION. I FILED ANOTHER PI ON HIS SAME PATIENT ONE WEEK AGO WHEN IT WAS DISCOVERED THIS PATIENT HAD ALREADY BEEN REVISED ON (B)(6) 2019, AGAIN DUE TO DISASSOCIATION OF HEAD WITH ADM INSERT. UPDATE 04/NOVEMBER/2019 WG: SALES REP REPORTED THAT THE TRITANIUM PRIMARY SHELL AND EXETER STEM WERE ALSO REVISED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9383084 ↗
• InjuryNov 19, 2019Fracture; Fracture

  PATIENT CAME TO HOSPITAL WITH PAIN IN BOTH HIPS. AFTER X- RAY SURGEON FOUND A BROKEN EXETER STEM. UPDATE (B)(6) 2019 WG: X-RAYS SHOW THAT THE PATIENT HAS IMPLANTS IN ONLY ONE HIP. THE OTHER HIP IS THE PATIENT'S NATIVE HIP.

  Patient problems: Pain

  MAUDE report 9340570 ↗