EXETER 0580-1-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540153227), received between Mar 4, 2019 and Sep 24, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23131613 ↗
• InjuryJul 22, 2024Failure to Osseointegrate; Migration; Failure to Osseointegrate; Migration

  IT WAS REPORTED BY SALES REPRESENTATIVE THAT PATIENT DID A LEFT MAKO PRIMARY THA ON (B)(6) 2024. CASE WENT WELL. HOWEVER PATIENT HAD SUFFERED A STROKE AND WAS SENT TO ICU. DURING A&E HANDLING, HER LEFT HIP GOT DISLOCATED. WHILE DR. TRIED TO RELOCATE THE HIP FOR PATIENT UNDER GA, FEMORAL STEM CAME OUT FROM CANAL. REVISION SURGERY IS PLANNED ON (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 19792459 ↗
• InjuryMar 27, 2024Fracture; Fracture

  THE STEM FRACTURE WAS FOUND. REVISION SURGERY IS NOT PLANNED YET.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18986187 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT PATIENT HAVE INFECTION THR. IMPLANT USED WAS STRYKER IMPLANT 33 STEM, V40 28/0. PREVIOUS OPERATION DATE IS: 16/2/2021

  Patient problems: Unspecified Infection

  MAUDE report 16814814 ↗
• InjuryMar 16, 2023Fracture; Fracture

  THERE WERE NO PROBLEMS AFTER THE OPERATION SEVEN YEARS AGO BUT WHEN THE PATIENT COMPLAINED OF FEMORAL DISCOMFORT, A CHECK REVEALED A BROKEN STEM.

  Patient problems: Ambulation or Postural Difficulties; Discomfort

  MAUDE report 16552949 ↗
• InjurySep 2, 2022Fracture; Fracture

  IT WAS REPORTED BY SALE REP THAT PROSTHETIC FRACTURES EXETER SIZE 33 DUE TO FALLS. REVISION SURGERY WAS DONE ON 12TH AUG WITH RESTORATION MODULAR AND DALL MILES.

  Patient problems: Fall

  MAUDE report 15353396 ↗
• InjuryJul 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A THIRD REVISION OF THIS PATIENT THAT IS MENTALLY AND PHYSICALLY CHALLENGED, AS IT HAS DISLOCATED AGAIN USING AN EXETER STEM AND HEAD. UPDATE (B)(6) 2021: REP CONFIRMED THAT THIS WAS THE PATIENTS 2ND REVISION, BUT THIRD CASE.

  Patient problems: Joint Dislocation

  MAUDE report 12146466 ↗
• InjuryMar 27, 2020Fracture; Fracture

  A PATIENT REPORTS PROGRESSIVE PAIN AND NO EVENT OF FALL OR KNOCK. ON (B)(6) 2020 SURGEON DECIDE TO REMOVE BROKEN EXETER V40 STEM AND CHANGE IT FOR A NEW ONE AND A FEMORAL HEAD WITH SIMPLEX BONE CEMENT WITH TOBRAMYCIN. THE SURGERY FINISHED SUCCESSFULLY, THE PATIENT HAD BEEN RECEIVED 2 SURGERIES BEFORE OF THIS; 2ND SURGERY HAVE BEEN PERFOMED ON SEPT, 2012 AND THE SURGEON REMOVED EXETER TOTAL HIP PROSTHESIS PLUS TRIDENT CUP. THEN IT WAS IMPLANTED ZIMMER (NOT STRYKER) CUP, INSERT AND SCREWS WITH EXETER STEM AND V40 HEAD. UPDATE: "1. PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE: NONE"

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Injury

  MAUDE report 9888009 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IN 2016 THE PATIENT HAS LEFT HIP JOINT OSTEOARTHRITIS AND HIP DYSPLASIA. IN ORDER TO RECOVER BACK HIP JOINT FUNCTIONS. THE PATIENT PERFORMED LEFT HIP REPLACEMENT PROCEDURE. THE ACT ACETABULAR CUP FROM AN EXTERNAL COMPANY ((B)(4) LOCAL COMPANY) AND EXETER V40 STEM FROM STRYKER WERE USED TO PATIENT. THE PATIENT ALWAYS FEEL THE LEFT HIP PAIN AFTER PROCEDURE. THE LEG DOESN¿T HAS POWER. THE PATIENT DIAGNOSED THAT THE FEMORAL PROSTHESIS WAS LOOSE AFTER LEFT HIP REPLACEMENT PROCEDURE. ON (B)(6) 2018, THE PATIENT PERFORMED LEFT HIP JOINT FEMORAL STEM REVISION SURGERY. THE REPORTED ISSUE DOESN¿T ANY MATTER WITH PROSTHESIS. AFTER REVISION SURGERY, THE PATIENT JOINT FUNCTIONS RECOVER BACK.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 8869444 ↗
• InjuryMar 4, 2019Break; Fracture; Break; Fracture

  PAIN COMPLAINED ON THE LEFT FOOT (AFFECTED LEG), SO VISITED TO THE HOSPITAL. IT HAS BOTH LEGS THA ON 2012/4/11 AND THIS TIME THE LEFT FOOT STEM IS BROKEN. REMOVED THE STEM, INSERTED THE SAME SIZE STEM AND REDUCED, BUT POSSIBILITY INTENDED TO DISLOCATE, SO REMOVE THE CUP. THE CUP IS COMPATIBLE WITH THE RIMFIT CUP. IMPLANTED STEM 33 + 4 HEAD 54 MM RIMFIT REPLACED.

  Patient problems: Injury

  MAUDE report 8386983 ↗