Lineage 26000008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684260000081), received between Mar 10, 2020 and Dec 2, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT IMPINGES ON MALPOSITION CUP. CUP WAS CUT OUT AND REPLACED WITH BIOMET CUP AND LINER W/SCREWS. NECK WOULD NOT CAME OUT W/OUR EXTRACTION, OUR HEAD WAS PULLED AND 28MM FROM MPO WAS PUT INTO A BIOMET DUAL MOBILITY HEAD. (RIGHT HIP) COMPONENTS NOT REVISED: PROFEMUR® NECK NEUTRAL / PRODUCT ID: PHA01202 / LOT NO: 065207269, PROFEMUR® Z STEM SIZE 6 STEM / PRODUCT ID: PHA00242 / LOT NO: U0366091.

  Patient problems: Loss of Range of Motion

  MAUDE report 10934845 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBJECT WAS SEEN IN EMERGENCY ROOM WITH RIGHT HIP PAIN FOR 2 WEEKS, CRUNCHING WITH MOTION AND DIFFICULTY AMBULATING. LINER FRACTURE WAS CONFIRMED BY X RAY AND CT OF THE HIP. SUBJECT HAD A REVISION AND REMOVAL OF THE ORIGINAL ACETABULAR, LINER, MODULAR NECK AND FEMORAL HEAD AND WAS DISCHARGED ON (B)(6) 2015.

  Patient problems: Pain

  MAUDE report 9813872 ↗