EXETER 0580-1-443Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540153326), received between Sep 10, 2018 and Feb 25, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Fracture; Fracture

  EXETER V40 44 #3 STEM SNAPPED AT SHOULDER LEADING TO IMPLANT FAILURE AND REVISION SURGERY. REVISION SURGERY TOOK PLACE ON (B)(6) 2025 WHERE BROKEN EXETER STEM WAS REMOVED AND REPLACED WITH THE SAME SIZE STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21462143 ↗
• InjuryNov 15, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: HIP REVISION SURGERY DUE TO PATIENT'S EXETER STEM 44 N3 BEING BROKEN AT NECK LEVEL.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15798863 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED A REVISION SURGERY FOR PERIPROSTHETIC FRACTURE OF HIP. PATIENT ADMITTED INTO HOSPITAL AFTER A TRIP AND FALL AT HOME.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 15672153 ↗
• InjurySep 23, 2021Fracture; Fracture

  THE SURGEON REPORTED "AN EVENT TOOK PLACE IN 2019: PATIENT 130KILOS, IMPLANT BROKE AT THE EXETER'S NECK (WITHOUT ANY NOTION OF PARTICULAR TRAUMA)".

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12518682 ↗
• InjuryMar 29, 2021Break; Break

  (B)(6)-YR OLD MALE HAD A FALL BACKWARDS. X-RAY SHOWED HIS RIGHT FEMORAL STEM WAS IN TWO PIECES. REVISION SURGERY WAS REQUIRED. 44MM#3 EXETER STEM WAS REMOVED AND REPLACED WITH ANOTHER INTO EXISTING CEMENT MANTLE. OPERATING SURGEON COMMENTED THAT THE 36MM +5 FEMORAL HEAD APPEARED TO BE ¿TWISTED AND STUCK¿ INSIDE THE ACETABULAR COMPONENT AND HE COMMENTED THAT HE BELIEVES THE STEM BROKE AT THE NECK AS A RESULT OF THE MECHANISM OF THE FALL.

  Patient problems: Fall

  MAUDE report 11581244 ↗
• InjuryMar 2, 2021Break; Fracture; Break; Fracture

  REVISION HIP SURGERY CASE. EXETER STEM REMOVED. IMPLANT HAD BROKEN AT THE NECK.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11398902 ↗
• InjuryJun 11, 2020Naturally Worn; Naturally Worn

  REVISION OF EXETER STEM. FAILED DUE TO SUSPECTED POLY WEAR (NON STRYKER). UPDATE: NO ALLEGATIONS WERE NOTED AGAINST THE EXETER STEM.

  Patient problems: Injury

  MAUDE report 10142880 ↗
• InjuryJun 12, 2019Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  REVISION OF EXETER TOTAL HIP REPLACEMENT. UPDATE 05/JUNE/2019 WG: AS REPORTED IN HOW WAS ISSUE NOTICED "PATIENT PRESENTED TO SURGEON WITH PAIN IN RIGHT HIP. RTHR PREVIOUS 5 YEARS". ADDITIONAL DETAILS PROVIDED BY REP: "DURING THE REVISION OPERATION THE REASON WAS EVIDENT WITH METALOSIS. FROM MY OBSERVATION THE FEMORAL HEAD WAS SITTING LOOSELY ON THE FEMORAL COMPONENT".

  Patient problems: Injury

  MAUDE report 8691300 ↗
• InjuryNov 9, 2018Break; Fracture; Break; Fracture

  A FRACTURED STEM NECK.

  Patient problems: Injury

  MAUDE report 8054822 ↗
• MalfunctionNov 7, 2018Use of Device Problem; Use of Device Problem

  SURGEON WAS PLACING DEFINITIVE EXETER IMPLANT ONTO THE STEM INTRODUCER. I NOTICED HE HAD PLACED THE WINGED CENTRALISER ONTO THE STEM FOR A SMALL CANAL. WE DISCUSSED HIS OPTION TO USE THE STRAIGHT CENTRALISER TO USE WITH ALONGSIDE THE SMALL ARTISAN PLUG. HE ACKNOWLEDGED MY SUGGESTION BUT CHOSE TO GO AHEAD WITH THE WINGED CENTRALISER. HE THEN ATTACHED THE IMPLANT ONTO THE STEM INTRODUCER AND WRAPPED A PACK OVER THE END OF THE STEM AND PLACED IT ON THE TABLE STILL WRAPPED IN THE PACK. HE THEN PICKED UP THE STEM, WRAPPED IN THE PACK SO THAT THE TIP WAS NOT VISIBLE AND PROCEEDED TO INSERT THE STEM INTO THE PATIENT/CEMENT. IT WAS THEN NOTICED BY THE STRYKER REPRESENTATIVE THAT THE CENTRALISER WAS ON THE TABLE BEHIND SOME RETRACTORS. THE REP BROUGHT THIS TO THE IMMEDIATE ATTENTION OF THE SURGEON TO WHICH HE REPLIED, ¿OH WELL, TOO LATE NOW¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047657 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NOTIFICATION OF LFIT HAZARD ALERT GIVEN TO OPERATING SURGEON AND HE CONTACTED PATIENT TO INFORM. SURGEON WAS ADVISED THAT THE PATIENT REQUIRED AN EARLY REVISION AS HAD A TISSUE REACTION. SURGEON REPORTS THAT THE PATIENT HAS HAD SUBSEQUENT PROBLEMS.

  Patient problems: Injury; Reaction

  MAUDE report 7862251 ↗