Alumina 6565-0-236Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540390516), received between Jun 28, 2018 and Jan 3, 2019 — classified as 2 injuries.

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

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.

• InjuryJan 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED ACUTELY TO HOSPITAL ON (B)(6) 2018 WITH PAIN, UNABLE TO WEIGHT BEAR AND DISLOCATED HIP. IT WAS NOTED THAT EXETER STEM WAS BROKEN AT NECK LEVEL. INITIAL OPERATION OCCURRED 9 YEARS EARLIER. REVISION SURGERY WAS PERFORMED AT (B)(6) HOSPITAL ON (B)(6) 2018 AND BROKEN STEM (44, #4) ALONG WITH 36+5 ALUMINA CERAMIC HEAD AND 36G ALUMINA CERAMIC LINER WERE REMOVED. CEMENT IN CEMENT REVISION OF STEM PERFORMED (50, #2) AND NEW 32+0 BIOLOX CERAMIC HEAD AND 32G 0 DEGREE X3 LINER IMPLANTED. REVISION SURGEON SAID THAT PATIENT HAD PREVIOUSLY DESCRIBED A ¿GRINDING SENSATION¿ IN THE HIP PRIOR TO BREAK. UPDATE 17 DECEMBER, 2018: INITIAL REPORTER STATED "THE REVISION SURGEON WANTED ME TO NOTE THAT A LOT OF THE DAMAGE TO THESE OCCURRED DURING THE REMOVAL OF THESE AND THERE WAS NO VISIBLE SIGN OF IMPINGEMENT THAT HE COULD SEE INTRAOPERATIVELY."

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Dislocation

  MAUDE report 8214786 ↗
• InjuryJun 28, 2018Break; Crack; Fracture; Break; Crack; Fracture

  THE CUSTOMER REPORTED THAT THE PATIENT WAS REVISED AS THE EXETER STEM WAS BROKEN AT THE TRUNNION. UPDATE: UPON INSPECTION OF RECEIVED OF THE DEVICES, THE CERAMIC HEAD WAS ALSO NOTED FRACTURED.

  Patient problems: Injury

  MAUDE report 7646851 ↗

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