EXETER 0580-3-422Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540153418), received between Apr 18, 2019 and Feb 28, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION THA WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE IMPLANT DEVICES (COMPETITOR PRODUCTS) WITH NEW ONES (STRYKER'S PRODUCTS) BECAUSE OF THE NECK FRACTURE OF THE COMPETITOR STEM. THE CUP WAS REPLACED SUCCESSFULLY, AND THE SURGEON BEGAN TO REPLACE THE STEM AS A NEXT STEP. HOWEVER, DURING STEM REPLACEMENT, THE PATIENT'S ELECTROCARDIOGRAM SUDDENLY SHOWED ABNORMAL WAVEFORMS AND HER CONDITION WORSENED. ALTHOUGH IT WAS NOT CONFIRMED PROPERLY, THE ANESTHESIOLOGIST WHO PARTICIPATED IN THE OPERATION STATED "IT'S A PULMONARY EMBOLISM" DURING A LIFESAVING PROCEDURE OF THE SUDDEN CHANGE IN THE PATIENT'S CONDITION, SO THERE IS A POSSIBILITY THAT THE PATIENT WENT INTO CARDIAC ARREST DUE TO A PULMONARY EMBOLISM. AS THE PATIENT WENT INTO CARDIAC ARREST, THE SURGERY DISCONTINUED, AND THE PATIENT MANAGED TO REGAIN CONSCIOUSNESS ON THE SAME DAY THROUGH 30 MINUTES OF CARDIAC MASSAGE AND ECMO. THE PATIENT'S FINAL OUTCOME AFTER REGAINING CONSCIOUSNESS IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD NO ABNORMALITIES SUCH AS PRIMARY DISEASE AT THE TIME OF SURGERY OTHER THAN STEM NECK FRACTURE. UPDATE: PATIENT DIED ON (B)(6) 2025 DUE TO A PULMONARY EMBOLUS.

  Patient problems: Cardiac Arrest; Embolism/Embolus; Pulmonary Embolism

  MAUDE report 21490697 ↗
• MalfunctionApr 18, 2019Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THE EXETER STEM WAS MISSING THE CENTRALISER. THE CASE WAS COMPLETED WITH ANOTHER STEM AND A SHORT DELAY UPDATE: THE CUSTOMER USED THE CENTRALISER FROM A ANOTHER STEM 05801352 IN CONJUNCTION WITH THE REPORTED STEM TO COMPLETE THE CASE. THE REPORTED DEVICE REMAINS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8526815 ↗