EXETER 0580-1-351Recalls & reported problems
Howmedica Osteonics Corp. · V40 STEM · Class 2 · Implant
All models of EXETER (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Exeter stem is a metal hip implant used in hip replacement surgery. The 28 reports mostly describe the stem breaking or snapping in the middle of its shaft, and the stem loosening or not growing into the bone, which led patients to have revision surgery; 26 reports involved injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04546540153234), received between May 11, 2017 and Sep 25, 2026 — classified as 27 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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.
Reports received per month
Most reported problems
Device problems
- Fracture16
- Adverse Event Without Identified Device or Use Problem6
- Loss of Osseointegration5
- Break2
- Osseointegration Problem2
- Degraded1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information10
- Ambulation or Postural Difficulties9
- Pain8
- Inadequate Osseointegration5
- Injury5
- Bone Fracture(s)1
- Fall1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fracture
The following information was provided: It was reported that the patient's Right hip was revised due to the Exeter stem breaking approximately 63-64mm from the distal tip. No trauma/ cause for implant breakage reported. No femoral fracture was observed. The stem, head, and liner were revised. Rep confirmed there were no allegations against the revised head and liner.
Patient problems: Insufficient Information
MAUDE report 50896023 ↗InjuryJun 11, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: BROKEN EXETER STEM BROKEN THROUGH MID-SHAFT OF STEM, REVISED TO LONG STEM EXETER.
Patient problems: Insufficient Information
MAUDE report 25477782 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 18, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 22833638 ↗InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR INFORMED ME THAT THE JOINT REPLACEMENT BEING PERFORMED THE FOLLOWING WEEK WAS A REVISION OF A HEMI ARTHROPLASTY TO A TOTAL HIP REPLACEMENT. HE GAVE ME NO OTHER DETAILS OTHER THAN THAT HE PLANNED TO USE A CEMENT IN CEMENT STEM.
Patient problems: Insufficient Information; Pain
MAUDE report 19400544 ↗InjuryMay 9, 2024Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
SUSPECTING A STEM LOOSENING, THE REVISION OF THE STEM WAS PERFORMED. WHEN THE STEM WAS REMOVED, IT WAS FOUND TO BE BROKEN OFF IN THE MIDDLE.
Patient problems: Inadequate Osseointegration
MAUDE report 19282331 ↗InjurySep 8, 2023Osseointegration Problem; Osseointegration Problem
REVISION OF RIGHT THA DUE TO LOOSE CEMENTED STEM. STEM, HEAD AND LINER WERE EXPLANTED. COMPETITOR STEM AND HEAD WERE IMPLANTED ALONG WITH STRYKER INSERT.
Patient problems: Inadequate Osseointegration
MAUDE report 17709670 ↗InjuryAug 10, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN THE MEDICAL RECORDS RECEIVED UNDER RELATED PI THAT THE PATIENT HAD AN INTRAOPERATIVE FRACTURE OF THE FEMUR AFTER IMPLANTATION OF THE STEM. PER THE PRIMARY OPERATIVE REPORT: "DURING REDUCTION, AVULSION OF THE MAJOR TROCHANTER OCCURRED AND A CERCLAGE WAS PERFORMED ON IT."
Patient problems: Bone Fracture(s)
MAUDE report 16655431 ↗InjuryMar 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
SURGEON REPORTED ON 21 FEBRUARY PATIENT REQUIRING REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 16552840 ↗InjuryFeb 24, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN, STIFFNESS, RESORPTION AND LOOSENING. SURGEON SUSPECTS THE CAUSE AS: "I THINK HER BODY IS REACTING TO AND REJECTING THE BONE CEMENT. AN ALLERGY HAS TO BE CONSIDERED." CEMENT WAS REMOVED AND THE STEM AND HEAD REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 16433968 ↗InjuryJan 28, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
PATIENT UNDERGOING ARTHROSCOPIC REVIEW DUE TO LOOSENING OF THE METALLIC HEAD OF THE NAIL CONE.
Patient problems: Pain
MAUDE report 16261371 ↗InjuryNov 17, 2022Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED BY THE SALES REP THAT THE SURGEON NOTIFY ON A POSSIBLE REMOVAL CASE DUE TO LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 15812795 ↗InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 15, 2022Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
REVISION WAS PLANNED DUE TO PAIN IN THE FEMORAL DIAPHYSIS. X-RAY SHOWED STEM FRACTURE. PATIENT WAS NOT VERY MUCH ACTIVE, BUT LOOSENING WAS FOUND IN THE PROXIMAL PART. MISMATCH WITH THE ADHERENT DISTAL PART MIGHT CAUSE STEM FRACTURE.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 13767289 ↗InjuryJan 12, 2022Break; Fracture; Break; Fracture
THE FOLLOWING WAS REPORTED: ¿REVISION SURGERY REQUIRED FOR AN EXETER STEM IMPLANTED ABOUT TEN YEARS AGO WHICH BROKE AT THE LEVEL OF THE HEAD. THE PATIENT SAID HE HEARD A CRACKING SOUND AND THEN HE FELL DOWN."
Patient problems: Ambulation or Postural Difficulties
MAUDE report 13236889 ↗InjuryNov 15, 2021Fracture; Fracture
BROKEN EXETER STEM. REVISION PROCEDURE BOOKED FOR POSSIBLY (B)(6) 2021.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 12813628 ↗InjuryAug 3, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2021Fracture; Fracture
IT HAS BEEN REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO BROKEN PROSTHESIS.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 11947180 ↗InjuryFeb 9, 2021Fracture; Fracture
PATIENT HAD COMPLAINED OF ONGOING THIGH PAIN AND PRESENTED TO HOSPITAL. PATIENT HAD A TOTAL HIP REPLACEMENT IN 2008. NO OTHER DETAILS ARE AVAILABLE AT THIS POINT IN TIME, AS THE RECORDS HAVE BEEN ARCHIVED. THE REGISTRAR IS CONTACTING MEDICAL RECORDS TO SEE IF THEY CAN GET A COPY OF THE 2008 RECORDS. PATIENT PRESENTED TO HOSPITAL ON (B)(6), COMPLAINING OF ONGOING RIGHT THIGH PAIN. THEY WERE X-RAYED AND THE X-RAY SHOWED THAT THE STEM IN-SITU HAD FRACTURED. PATIENT IS SCHEDULED FOR A REVISION HIP REPLACEMENT ON (B)(6) AT THIS STAGE. PLAN IS TO REVISE THE STEM ONLY WITH EITHER A RESTORATION MODULAR STEM OR LONG STEM EXETER. NO FURTHER DETAILS ARE AVAILABLE AT THIS STAGE.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 11305272 ↗InjuryDec 2, 2020Fracture; Fracture
BROKEN EXETER STEM DUE TO PATIENT FALL. WAS NOTICED ON XRAY THAT WAS DONE FOLLOWING THE FALL.
Patient problems: Ambulation or Postural Difficulties; Fall
MAUDE report 10935601 ↗InjuryNov 10, 2020Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE LEFT HIP AND THE XRAY SHOWED A STEM FRACTURE. THE STEM WAS THEREFORE REVISED SUCCESSFULLY TO A RESTORATION MODULAR STEM.
Patient problems: Insufficient Information; Pain
MAUDE report 10816805 ↗InjuryJun 10, 2020Fracture; Fracture
REVISION HIP SURGERY REQUIRED ON A PATIENT DUE TO IMPLANT CRACKING. STRYKER EXETER STEM BROKE IN THE PATIENTS FEMUR AFTER BEING IMPLANTED IN 2003. WE REMOVED THE BROKEN STEM AND REPLACED IT WITH A CEMENT IN CEMENT REVISION STEM. PATIENT CAME IN WITH PAIN TO HIP. PICKED UP ON X-RAY.
Patient problems: Injury; Pain
MAUDE report 10139482 ↗InjuryDec 26, 2019Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN LEFT HIP. UPON X-RAY A FRACTURE OF STEM WAS NOTICED.
Patient problems: Ambulation or Postural Difficulties; Injury; Pain
MAUDE report 9520429 ↗InjuryNov 5, 2019Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "PROCEDURE: I&D AND HEAD AND [COMPETITOR] LINER EXCHANGE. PRE-OP DIAGNOSIS: SEPTIC VS. ASEPTIC LOOSENING STATUS POST COMPLEX PRIMARY RIGHT TOTAL HIP. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL". A 32 -4 BIOLOX HEAD WAS REVISED TO A 32 BIOLOX HEAD WITH -2.5 SLEEVE. SPOKE TO REP. PATIENT WAS REVISED DUE TO INFECTION. REP PROVIDED PRE-REVISION X-RAYS AND A USAGE SHEET FROM THE PRIOR PROCEDURE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 08 OCTOBER, 2019: REVIEW OF THE X-RAY BY A CLINICIAN CONFIRMS LOOSE CEMENTED STEM.
Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection
MAUDE report 9281832 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 reports
- REFLECTION 71336500Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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