Alumina 6565-0-128Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540390462), received between Jul 6, 2017 and Jan 14, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2024Fracture; Fracture

  CUSTOMER REPORTED : "HIP REVISION RIGHT SIDE FOR SHATTERED ALUMINA CERAMIC HEAD."

  Patient problems: Insufficient Information

  MAUDE report 18509784 ↗
• InjuryJan 23, 2023Fracture; Fracture

  THE FOLLOWING WAS REPORTED: THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN AND A SHORTER LIMB. DURING REVISION SURGERY ON THE (B)(6) 2022 IT WAS FOUND THAT THE CERAMIC HEAD HAD CRACKED AND CHIPPED. THE PATIENT'S CERAMIC HEAD WAS REPLACED WITH A METAL ONE AND THE MDM INSERT WAS REPLACED WITH A NEW ONE.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 16223446 ↗
• InjuryJun 10, 2021Unstable; Unstable

  A 2012 OPERATIVE REPORT FOR THE PATIENT'S LEFT HIP WAS PROVIDED. NOTED IN THE REPORT: "INSTABILITY OF THE LEFT HIP JOINT SECONDARY TO CEMENTLESS TOTAL HIP REPLACEMENT ON THE LEFT...FEMORAL HEAD EXCHANGE, REVISION TO A METAL HEAD, DIAMETER 28MM, LENGTH +12MM, TAPER V40...JOINT IS OPENED FROM THE DORSAL, REVEALING MINOR EFFUSION. A SMEAR IS SENT IN FOR BACTERIOLOGY...NO LONGER POSSIBLE TO ATTACH A CERAMIC HEAD, BECAUSE THE PROSTHESIS TAPER EXHIBITED SCRATCHES AND AN EXTENSION BY 12MM WITH CERAMIC HEAD, DIAMETER 28MM, IS NOT POSSIBLE." THE REPORT NOTES A 45 MINUTE INTRA-OPERATIVE DELAY TO HAVE THE NEW FEMORAL HEAD DELIVERED BY TAXI AS ONE WAS NOT AVAILABLE IN THE O.R. AN OPERATIVE REPORT FOR A REVISION ON (B)(6) 2016 NOTES: "STATUS SECONDARY TO REVISION OF THE MODULAR HEAD SYSTEM PERFORMED ON (B)(6) 2012 IN THE PRESENCE OF RECURRENT DISLOCATION." ONLY THE FEMORAL HEAD WAS REVISED IN 2012.

  Patient problems: Joint Laxity

  MAUDE report 11972735 ↗
• InjuryJun 19, 2018Break; Fracture; Break; Fracture

  THE SURGEON REVISED A FAILED EXETER / CONTEMPORARY CUP. THE SURGEON REPORTED A SHATTERED FEMORAL HEAD AND A VERY WORN FEMORAL TRUNNION. UPDATE: ONE YEAR FOLLOW UP X-RAY SHOWED A CERAMIC HEAD FRACTURE.

  Patient problems: Injury

  MAUDE report 7615744 ↗
• MalfunctionJul 6, 2017Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  WHEN THE SURGEON WENT TO OPEN THE BLISTER PACK IT WAS NOTICED THAT THE INNER AND OUTER SEAL WERE STUCK TOGETHER. SURGEON USED ANOTHER IMPLANT. THERE WAS NO DELAY IN SURGERY.

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

  MAUDE report 6691984 ↗

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