Alumina 6565-0-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540390479), received between Sep 5, 2018 and Nov 5, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Incompatible” (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.

• InjuryNov 5, 2019Component Incompatible; Mechanical Problem; Component Incompatible; Mechanical Problem

  THE V40 FEMORAL HEAD WAS VERY LOOSE AFTER INSTALLED. FINALLY, THE SURGEON USED 32+0MM FEMORAL HEAD TO FINISH MEDICAL PROCEDURE. UPDATE: THE COMPLAINT ISSUE RESULT IN PATIENT'S LEG LENGTH DISCREPANCY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9278433 ↗
• InjurySep 5, 2018Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT, IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT ACETABULAR HIP STEM. IT WAS FURTHER ALLEGED THAT THE PATIENT "BEGAN EXPERIENCING AUDIBLE SOUNDS DURING MOTION EMANATING FROM LOCATION OF THE DEVICE." EVENT UPDATE PER REVIEW OF THE MEDICAL RECORDS: "ON (B)(6) 2009 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY FEMORAL HEAD AND ACETABULAR INSERT WAS PERFORMED FOR A DIAGNOSIS OF A PAINFUL LEFT HIP, CATCHING AND CLICKING. THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND USE OF THE PREVIOUS INCISION. SCAR TISSUE WAS NOTED AROUND THE NECK AND WAS EXCISED. THE REPORT STATES THE LINER "LOOKED FINE ... QUITE A BIT OF SHUCK". THE LINER WAS CHANGED TO A 36/0° X3 POLY INSERT AND THE HEAD WAS CHANGED TO A 36/0 LFIT V-40 METAL HEAD. UNCOMPLICATED SURGERY WAS DESCRIBED AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2009."

  Patient problems: Injury; Pain; Scar Tissue

  MAUDE report 7845925 ↗

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