Alumina 6565-0-228Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540390493), received between Mar 19, 2020 and Mar 19, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2020Noise, Audible; Noise, Audible

  WHILE CONVERSING WITH A SURGEON REGARDING A PATIENT WITH AN ALLEGED KNEE CONSTRUCT WITH SQUEAKING, THE SURGEON SENT THE FOLLOWING MESSAGE: "JUST RECEIVED THE IMPLANT STICKERS OF THE RIGHT HIP REPLACEMENT OF THE PATIENT WITH THE SQUEAKING. SHE DOES HAVE A CERAMIC ON CERAMIC HIP REPLACEMENT WHICH COULD BE THE SOURCE OF THE SQUEAKING." IMPLANT STICKERS OF THE HIP, IMPLANTED IN 2005, ARE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857603 ↗

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