Alumina 6565-0-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540402127), received between Apr 12, 2017 and Jun 21, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K023901, K173499, K243784); they may or may not involve this specific model.

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 18, 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.

• InjuryJun 21, 2018Break; Crack; Fracture; Break; Crack; Fracture

  THE SURGEON REPORTED THAT HE UNDERTOOK A REVISION OF A CERAMIC HEAD AND ACCOLADE STEM. THE PATIENT PRESENTED WITH PAIN. DURING THE REVISION IT WAS NOTED THAT THE CERAMIC HEAD HAD FRACTURED INTO 2 PIECES. THE REVISION WAS COMPLETED SUCCESSFULLY WITH AN ETO PROCEDURE.

  Patient problems: Injury; Pain

  MAUDE report 7625455 ↗
• InjuryApr 12, 2017Fracture

  THE CUSTOMER REPORTED THAT HE WILL BE UNDERTAKING A REVISION OF AN EXETER/ 32MM ALUMINA FEMORAL HEAD WITH TRIDENT X3 POLY IN A 65 YEAR OLD FEMALE OF 80KG¿S WEIGHT. THE PRIMARY WAS DONE IN (B)(6) 2016. THE PATIENT HAS BEEN TO CLINIC AND THE X-RAY SHOWED THE FEMORAL HEAD HAS FRACTURED. THE CUSTOMER FURTHER REPORTED THAT THERE WAS NOTHING UNUSUAL ABOUT THE PRIMARY SURGERY.

  Patient problems: Injury; No Code Available

  MAUDE report 6485884 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023901, K173499, K243784. One submission often covers many models, so check the product and lot details in each record.

• Z-0314-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
• Z-0313-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028