EXETER 0580-1-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 04546540153296), received between Nov 8, 2017 and Sep 16, 2026 — classified as 83 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (65 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 30, 2021Terminated

   There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

   Z-0652-2022 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50794460 ↗
• InjurySep 16, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50794459 ↗
• InjuryAug 26, 2026Fracture

  It was reported that the patient was having some pain and was booked for a revision because of the osteolytic lesion in femur. Surgeon was in Operating Room for surgery had dislocated the hip and pulled on the stem with his hand and out came a broken stem. Device has been in service since (b)(6) 2012. Stem was removed. ETO performed, Cement removed and a new revision Restoration Modular stem put back with Dall Miles cables.

  Patient problems: Osteolysis; Pain

  MAUDE report 50453263 ↗
• InjuryMay 27, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION HIP REPLACEMENT FOR REMOVAL OF BROKEN EXETER STEM. DIFFICULT EXTRACTION. REPLACEMENT EXETER CEMENT IN CEMENT STEM USED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25301273 ↗
• InjuryMay 19, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THERE WAS A BROKEN EXETER STEM. THE PATIENT PRESENTED IN EMERGENCY WITH PAIN. X-RAY TAKEN. SHOWED FX OF STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 25213724 ↗
• InjuryMay 19, 2026Fracture

  No new information.

  Patient problems: Insufficient Information

  MAUDE report 25213716 ↗
• InjuryFeb 9, 2026Degraded; Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: SUSPECTED STEM LOOSENING (NO LOOSENING DETECTED BY ORTHOPEDIC SURGEON'S IMAGING, BUT SLIGHT LOOSENING IDENTIFIED BY RADIOLOGIST'S INTERPRETATION) LED TO REMOVAL OF THE EXETER STEM. DISCOLORATION WAS OBSERVED ON THE REMOVED STEM, PROMPTING A REQUEST FOR INVESTIGATION; HOWEVER, THE STEM WAS DISCARDED BY THE HOSPITAL. NO COMPLICATIONS OR ADVERSE EVENTS OCCURRED DURING THIS PROCEDURE ITSELF.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24298569 ↗
• InjuryJan 28, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: BROKEN EXETER STEM AT NECK JUNCTION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 24203071 ↗
• InjuryOct 3, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23208296 ↗
• InjuryAug 25, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED: ON THE (B)(6) 2025, REVISION OF BROKEN EXETER STEM. NO SPECIFIC TRAUMATIC CAUSE NOTED FOR THE BROKEN STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22890124 ↗
• InjuryJun 17, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED: ""I IMPLANTED THIS HIP BACK IN 2017. LEG GAVE WAY YESTERDAY WHILST MOWING THE LAWN. STEM FRACTURE AT NECK ¿ VERY ODD!"

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22250632 ↗
• InjuryJun 4, 2025Fracture; Fracture

  FAILED EXETER STEM FROM 2017 WAS REVISED (B)(6) 2025. FAILED AT AN UNUSUAL LOCATION ABOUT HALFWAY DOWN WHERE THE STEM SNAPPED IN HALF.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22139531 ↗
• InjuryApr 7, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 21787402 ↗
• InjuryNov 13, 2024Fracture; Fracture

  REVISION SURGERY FOR STEM, CONFIRMED TO BE EXETER STEM, NECK OF STEM BROKEN, REPLACED WITH NEW EXETER STEM AND HEAD.

  Patient problems: Insufficient Information

  MAUDE report 20672831 ↗
• InjurySep 10, 2024Fracture; Fracture

  BROKEN EXETER STEM. REVISION SURGERY REQUIRED. BOOKED FOR (B)(6) 2024. ADDITIONAL INFORMATION PROVIDED: THE FIRST STAGE REVISION SURGERY FOR THIS WENT AHEAD AS PLANNED YESTERDAY (B)(6) HERE IS SOME MORE INFORMATION I HAVE BEEN ABLE TO ESTABLISH. THE ORIGINAL SURGERY WAS PERFORMED ABOUT 8 YEARS AGO. A SINUS DEVELOPED IN THE FEMORAL CANAL LEADING TO A CHRONIC INFECTION. BROKEN DISTAL STEM WAS WELL FIXED IN CANAL. THE REST OF STEM WAS LOOSE & PULLED OUT EASILY.

  Patient problems: Ambulation or Postural Difficulties; Unspecified Infection

  MAUDE report 20181561 ↗
• InjuryJul 2, 2024Fracture; Fracture

  AS DESCRIBED BY REP: "I'D LIKE TO REPORT THE FOLLOWING BROKEN EXETER STEM WHICH WAS REVISED TODAY. (B)(6) 2024 PRESENTED WITH PROSTHETIC FRACTURE. WALKING TO BEDROOM FELT SNAP/POP AND UNABLE TO WB." ADM X3 LINER, HEAD AND STEM WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19657240 ↗
• InjuryApr 24, 2024Fracture; Fracture

  BROKEN EXETER STEM AT NECK/SHOULDER JUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 19174605 ↗
• InjuryMar 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY TOTAL HIP WITH EXETER TRIDENT AT THE MONCTON HOSPITAL IN 2019. THE PATIENT SUBSEQUENTLY PRESENTED WITH LEFT HIP PAIN. THE PATIENT UNDERWENT A REVISION HIP ARTHROPLASTY WHICH SEEM TO BE A FRACTURED EXETER STEM.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18957859 ↗
• InjuryJan 26, 2024Fracture; Fracture

  REVISION SURGERY DUE TO BROKEN EXETER STEM. STEM WAS REVISED DUE TO BREAKING AT THE CALCAR/TRUNNION. ANOTHER COMPANY WAS USED FOR THE REMAINDER OF THE PROCEDURE. ORIGINAL SURGERY PERFORMED ROUGHLY 15 YEARS AGO.

  Patient problems: Insufficient Information

  MAUDE report 18586109 ↗
• InjuryJan 23, 2024Fracture; Fracture

  REVISED A HIP PATIENT DUE TO AN EXTER STEM FRACTURING AT THE NECK. I BELIEVE THE PRIMARY PROCEDURE WAS PERFORMED AROUND 10 YEARS AGO. FOLLOWING 10 YEARS OF BEING IN-SITU THE STEM HAS FRACTURED. I DO NOT BELIEVE THERE WAS ANY TRAUMA-RELATED INCIDENT THAT CAN BE IDENTIFIED AS CAUSING THIS FRACTURE. UPDATE: I BELIEVE THE PRIMARY PROCEDURE WAS PERFORMED AROUND 10 YEARS AGO. FOLLOWING 10 YEARS OF BEING IN-SITU THE STEM HAS FRACTURED. I DO NOT BELIEVE THERE WAS ANY TRAUMA-RELATED INCIDENT THAT CAN BE IDENTIFIED AS CAUSING THIS FRACTURE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 18561880 ↗
• InjuryDec 11, 2023Fracture; Fracture

  SALES REP REPORT: "I DON'T HAVE MUCH INFORMATION YET BUT WOULD LIKE TO REPORT A BROKEN EXETER STEM. THE STEM IS CURRENTLY BEING DECONTAMINATED SO IF YOU CAN PROVIDE A RETURNS NUMBER I'LL GET IT BACK TO YOU WHEN IT IS READY, PLEASE? SURGERY (B)(6) 2023 - REVISION OF PRIMARY EXETER STEM DUE TO IT BREAKING AROUND NECK AREA."

  Patient problems: Fall; Insufficient Information; Pain

  MAUDE report 18307854 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS DESCRIBED BY PATIENT: "I HAD A HIP REPLACEMENT. THE JOINT ¿FAILED¿ THIS YEAR. THE CONSULTANTS AT THE HOSPITAL WHERE I HAD THE HIP REVISION DONE MENTIONED THAT THE ORIGINAL HIP WAS MADE BY STRYKER. I¿M REALLY KEEN TO UNDERSTAND THE CAUSE OF THE FAILURE, THERE WAS NO TRAUMA, ACCIDENT OR FALL INVOLVED. GOING UP THE STAIRS TO BED MY RIGHT LEG ¿GAVE WAY¿. WHAT INFORMATION DO I NEED TO PROVIDE YOU WITH SO THAT YOU CAN IDENTIFY THE IMPLANT AND HELP ME UNDERSTAND THE CAUSE OF THE FAILURE? I¿M IN THE LATTER STAGES OF MY RECOVERY FROM THE PROCEDURE BUT IT¿S BEEN A LONG HAUL AND I AM REALLY KEEN TO AVOID ANY REPETITION OF THIS FAILURE." UPDATE PER RESPONSE: ISSUE OCCURRED "GOING UP THE STAIRS TO BED MY RIGHT LEG ¿GAVE WAY¿ WITH NO FALL OR OTHER TRAUMA".

  Patient problems: Insufficient Information

  MAUDE report 18044008 ↗
• InjuryOct 20, 2023Fracture; Fracture

  THE EXETER STEM WAS IMPLANTED IN 2018. X-RAY DEMONSTRATES A BROKEN EXETER STEM, WHILE STILL IMPLANTED. THE PATIENTS HIP HAD TE BE REVISED ON FRIDAY (B)(6) 2023.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17972179 ↗
• InjuryAug 22, 2023Fracture; Fracture

  THE FOLLOWING WAS REPORTED: REVISION HIP SURGERY FOR AN EXETER STEM THAT'S SNAPPED AT THE NECK IN SITU.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17600522 ↗
• InjuryJun 15, 2023Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THAT: "PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 2011 WITH THE EXETER HIP SYSTEM FOR AN ARTHRITIC LEFT HIP. PATIENT CLAIMS THAT HE HEARD A POP AS HE HOPPED ON ONE LEG TO PUT HIS PANTS ON. HE ALLEGEDLY BROKE HIS EXETER STEM. STEM IS BEING REVISED USING A CEMENT TECHNIQUE WITH A NEW EXETER STEM."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17140434 ↗