Alumina 6565-0-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540390486), received between Sep 11, 2019 and Nov 14, 2023 — 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.

• InjuryNov 14, 2023Fracture; Fracture

  "THE PATIENT HAD PAIN AND MOBILITY DIFFICULTIES." "THE IMPLANT BROKE INSIDE THE PATIENT. A SURGICAL RE-APPROACH WAS PERFORMED, CHANGING THE HEAD AND INSERT."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18136314 ↗
• InjurySep 11, 2019Break; Fracture; Break; Fracture

  THE SURGEON REPORTED THAT HE UNDERTOOK A REVISION OF A TRIDENT EXETER HIP. THE CUSTOMER REPORTED THAT THE EXETER TRUNNION WAS WORN. THE CERAMIC HEAD WAS BROKEN AND THE LINER HAD WEAR MARKS.

  Patient problems: Injury

  MAUDE report 8997526 ↗

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