EXETER 0580-3-441Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327123791), received between Aug 15, 2019 and Jan 26, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DR...PERFORMED A LEFT HIP REVISION DUE TO PERI-PROSTHETIC FRACTURE." A RESTORATION ADM/MDM INSERT, UNIVERSAL CEMENT RESTRICTOR-DISPOSABLE INSERTER, V40 HEAD, AND EXETER CEMENTED STEM WERE REVISED. SPOKE TO REP: THERE ARE NO ALLEGATIONS AGAINST ANY OF THE IMPLANTS. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND EXPLANTS ARE HOSPITAL RETAINED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11232821 ↗
• InjuryOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. AN ACCOLADE II STEM AND BIOLOX FEMORAL HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 10739032 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE INTRA-OPERATIVE FRACTURE WHICH OCCURRED ON (B)(6) 2019. AS REPORTED IN: "...THE SURGEON REPORTED THE STEM HAD BEEN IMPLANTED ON (B)(6) 2019 AND A BREACH OF THE FEMORAL CORTEX HAD OCCURRED AT THE TIME OF THE SURGERY. THIS WAS TREATED WITH DALL MILES CABLES..."

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8896550 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A SHORT 44 NO 1 EXETER STEM WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE AT THE TIP OF THE STEM. THE SURGEON REPORTED THE STEM. HAD BEEN IMPLANTED (B)(6) 2019 AND A BREACH OF THE FEMORAL CORTEX HAD OCCURRED AT THE TIME OF THE SURGERY. THIS WAS TREATED WITH DALL MILES CABLES, BUT SUBSEQUENTLY WENT ON TO FRACTURE DISTAL TO THE STEM TIP.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8896506 ↗