Biolox 6519-1-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540608420), received between Jul 22, 2019 and Oct 29, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "REV RTHA- PATIENT DISLOCATED FROM A COMPETITOR CUP AND CUSTOM TRIFLANGE." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 20557473 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION RIGHT TOTAL HIP DUE TO LOOSE ACETABULAR SHELL. REVISED TO A COMPETITOR SHELL. THE SLEEVE AND HEAD WERE ALSO REMOVED BUT WE WERE NOT ABLE TO IDENTIFY REFERENCE NUMBERS. NO ADDITIONAL INFORMATION PROVIDED BY THE FACILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19174607 ↗
• InjuryAug 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISED A LEFT TOTAL HIP HEAD/SLEEVE DUE TO DISLOCATION. PATIENT SINCE DISLOCATED AND WAS REVISED TO A COMPETITOR CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 17438956 ↗
• InjuryJul 22, 2019Fracture; Fracture

  AS REPORTED: "FRACTURED CERAMIC FEMORAL HEAD. LEFT HIP." A BIOLOX CERAMIC HEAD, ALUMINA INSERT, AND ADAPTER SLEEVE WERE REVISED TO STRYKER DEVICES.

  Patient problems: Injury

  MAUDE report 8811331 ↗

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