EXETER 0580-1-371Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540153258), received between Mar 21, 2018 and Aug 6, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bone Fracture(s)

  MAUDE report 50160579 ↗
• InjuryNov 25, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23643395 ↗
• InjuryNov 15, 2023Malposition of Device; Malposition of Device

  THA WAS PERFORMED FOR LEFT HIP OF THE FEMALE PATIENT ON (B)(6), 2023. THE REVISION SURGERY WAS PERFORMED ON (B)(6), 2023 BECAUSE OF FREQUENT DISLOCATIONS. ACCIDENTLY, THE EXETER V40 STEM AND THE DELTA V40 CERAMIC HEAD WERE IMPLANTED IN COMBINATION IN THE REVISION SURGERY. THE SURGEON DECIDES THAT THE STEM AND THE HEAD ARE LEFT AS THEY ARE IN THE PATIENT'S HIP AND WILL KEEP MONITORING. THE ISSUE WAS THAT THE CUP WITH THE LINER WAS COME OFF (DISLOCATED) WHILE THE HEAD WAS FIXED TO THE STEM. BECAUSE THE DOCTOR TOOK INTO CONSIDERATION THE FACT THAT THE CUP WAS INSTALLED AT AN INCORRECT ANGLE AND THE ANTEVERSION ANGLE OF THE STEM WAS TOO SHARP, THE ENTIRE IMPLANT PRODUCTS, INCLUDING NOT ONLY THE CUP AND LINER BUT ALSO THE HEAD AND STEM, WERE REPLACED. THIS RECORD WAS OPENED FOR REVISION SURGERY BY FREQUENT DISLOCATIONS AND INCORRECT COMBINATION IMPLANTATION IN THE REVISION SURGERY WAS OPENED IN ANOTHER RECORD.

  Patient problems: Joint Dislocation

  MAUDE report 18144495 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRIDENT II STUDY, IMMEDIATELY AFTER SURGERY, AN X-RAY SHOWED A FEMORAL FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17347692 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ADMITTED TO HOSPITAL FOLLOWING A FALL RESULTING IN PERIPROSTHETIC FRACTURE. REVISION SURGERY RESULTING IN REPLACEMENT PROSTHESES BEING IMPLANTED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16127097 ↗
• InjuryOct 16, 2020Fracture; Fracture

  STEM BROKE INSIDE THE PATIENT. IT WAS NOTICED AFTER THE PROCEDURE. IMPLANTATION DATE AND INITIAL PROCEDURE WAS (B)(6) 2009, AND ON (B)(6) 2020 A REVISION SURGERY WAS NECESSARY. SIGNIFICANT PATIENT MEDICAL HISTORY: OBESITY.

  Patient problems: Insufficient Information

  MAUDE report 10689386 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  EXETER TRIDENT IMPLANTS REMOVED DUE TO PT INFECTION. EXETER CEMENT IN CEMENT REVISION STEM & LFIT FEMORAL HEAD IMPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8420387 ↗
• InjuryNov 20, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  THE CUSTOMER REPORTED THAT DURING A REVISION CASE, THE SURGEON HAD PLANNED TO REVISE A CUP AND WHEN THE PATIENT WAS OPENED, HE REALIZED THAT THE STEM WOULD ALSO NEED REVISING. THE EXETER STEM WAS DIFFICULT TO REMOVE. IT HAD TO BE REMOVED USING A FLEXIBLE OSTEOTOME AND THE REMOVAL PROCESS ADDED 20 MINUTES TO THE SURGERY. THE CUSTOMER ALLEGES THAT THE STEM WAS TARNISHED AND THAT THIS MAKES THE STEM MORE LIKELY TO STICK IN THE FEMORAL CANAL BECAUSE THE POLISHED SURFACE IS NOT LONGER THERE AND THAT HAD THE DEVICE BEEN MADE OF COCR THEN THE TARNISHING WOULD NOT HAVE OCCURRED.

  Patient problems: Injury

  MAUDE report 8091558 ↗
• InjuryOct 30, 2018Break; Fracture; Break; Fracture

  EXETER STEM BROKE 1.5 YEARS AFTER IMPLANTATION.

  Patient problems: Injury

  MAUDE report 8021980 ↗
• InjuryMar 21, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE REVISION SURGERY WITH EXETER STEM FOR FRACTURE AFTER BHA SURGERY USING A COMPETITOR STEM. AFTER THE CEMENT WAS INSERTED INTO MEDULLARY CAVITY, THE STEM AND THE CENTRALIZER WERE INSERTED. AFTER THAT, THE STEM WAS REMOVED AND THE CENTRALIZER WAS LEFT IN THE MEDULLARY CAVITY AND THE SURGEON WAS NOT ABLE TO FIND THE CENTRALIZER. THEREFORE THE STEM WAS INSERTED WITHOUT CENTRALIZER AND THE OPERATION WAS FINISHED. DISTAL OF THE STEM WAS DEVIATED AT BY THE FRACTURE LINE AFTER SURGERY X-P. ALTHOUGH THE TIMING IS UNDECIDED YET, THE SURGEON PLAN TO OPERATE THE PLATE ON THE STEM.

  Patient problems: Injury

  MAUDE report 7357605 ↗