Lineage 26000009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684260000091), received between Feb 22, 2021 and Feb 22, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2021Separation Failure; Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO LEG LENGTH DISCREPANCY OF ABOUT 4MM ON THE RIGHT SIDE. RADIOGRAPHIC IMAGES SHOWED POSSIBLE LOOSENING OF CUP AND STEM. THE REVISION WAS SCHEDULED TO REPLACE THE HEAD AND NECK AND POSSIBLY THE LINER. WHEN TRYING TO REMOVE THE NECK FROM THE STEM, IT COULD NOT BE SEPARATED. SO THE STEM WAS ALSO REMOVED. ADDITIONAL INFORMATION RECEIVED ON 02/02/2021: REVISED PART AND LOT NUMBERS WERE PROVIDED AS WELL AS THE REASON FOR REVISION, MOREOVER THE REVISION SURGERY DATE.

  Patient problems: Unequal Limb Length

  MAUDE report 11357861 ↗