Alumina 6565-0-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540402134), received between Jul 26, 2018 and Sep 16, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Fall

  MAUDE report 23062072 ↗
• InjuryMar 26, 2021Fracture; Fracture

  BROKEN CERAMIC CUP. UPDATED EVENT AS PER SALES REP: THIS WAS REVISION DUE THE FACT THAT THE CERAMIC HEAD WAS BROKEN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575388 ↗
• InjuryJul 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CALLER REPORTED THAT HER HUSBAND HAD AN ABG TRIDENT CERAMIC ON CERAMIC HIP IMPLANTED IN (B)(6) 2008 AND HAS HAD PAIN SINCE THE IMPLANTS WERE PUT IN. THE PATIENT IS REPORTED TO LIMP AND HAS ALSO BEEN KNOWN TO COLLAPSE. HE IS CURRENTLY USING CRUTCHES TO HELP HIS MOBILITY. THE SURGEON EXPLAINED THAT ON X-RAY THE MECHANICS OF THE HIP LOOK OK AND THAT THE REPORTED PAIN COULD BE THE RESULT OF SCAR TISSUE. THE SURGEON HAS PRESCRIBED PAIN RELIEF. THE CALLER WOULD LIKE TO KNOW IF THIS PARTICULAR ABG DEVICE WAS AFFECTED UNDER A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10245095 ↗
• InjuryJul 26, 2018Noise, Audible; Noise, Audible

  A LETTER WAS RECEIVED FROM THE ((B)(6)) IN RELATION TO A MALE PATIENT WHO ALLEGED PERSONAL INJURY. THE (B)(6) REPORTED THAT ON (B)(6) 2012, THE PATIENT VISITED HIS GP COMPLAINING OF AN UNUSUAL SENSATION IN HIS RIGHT KNEE FOLLOWING TOTAL HIP REPLACEMENT. THE (B)(6) REPORTED THAT THE GP REFERRED THE PATIENT TO AN ORTHOPEDIC SURGEON WHO ADVISED THAT THE PATIENT HAD DEVELOPED A SQUEAKING OF HIS RIGHT HIP. THE SURGEON FURTHER ADVISED THAT REVISION SURGERY WOULD BE REQUIRED AND SUBSEQUENTLY PERFORMED A TOTAL HIP REPLACEMENT REVISION PROCEDURE ON (B)(6) 2012. THE (B)(6) REPORTED THAT APPROXIMATELY 5 - 6 MONTHS POST SURGERY, THE PATIENT DEVELOPED SIGNIFICANT PROBLEMS INCLUDING DISCOMFORT AND PAIN. THE SURGEON REFERRED THE PATIENT TO FOR ALLEGED ACUTE SHORTENING, PAIN AND FAILURE OF INTEGRATION. A SECOND REVISION PROCEDURE WAS PERFORMED BY ON (B)(6) 2013. THIS PI REFERS TO THE FIRST REVISION PROCEDURE PERFORMED ON (B)(6) 2012.

  Patient problems: Discomfort; Injury; Pain

  MAUDE report 7722914 ↗

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