Biolox 6519-1-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540608444), received between Oct 7, 2019 and Jul 30, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K070885, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. AN I&D WITH HEAD AND (COMPETITOR) LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22663107 ↗
• InjuryNov 27, 2019Unstable; Unstable

  DR. (B)(6) REVISED A RIGHT HIP HEAD/SLEEVE DUE TO PATIENT INSTABILITY. HE REVISED FROM A 40 -2.5 TO A +4. ORIGINAL SURGERY WAS (B)(6) 2019 BY MAKO. UPDATE 31/OCTOBER/2019 WG: REP PROVIDED USAGE SHEETS FROM PRIMARY AND REVISION PROCEDURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. REP ALSO CONFIRMED HE WAS THE ACTING MPS FOR THE PRIMARY PROCEDURE, AND THAT THE LOG AND SESSION FILES ARE NOT AVAILABLE FROM THE JULY PROCEDURE.

  Patient problems: Injury

  MAUDE report 9385369 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON AN UNKNOWN DATE. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9164890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070885, 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