Lineage 26000005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684260000051), received between Apr 21, 2020 and Dec 31, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REMOVING ITEMS FROM HIS STORAGE UNIT AND FELT A LARGE POP IN HIS HIP AND FELL TO THE GROUND. HE WAS TAKEN TO THE EMERGENCY ROOM DUE TO PAIN AND WAS DIAGNOSED WITH FEMORAL NECK FRACTURE. ON OR ABOUT (B)(6) 2021 DUE TO THE FAILURE OF THE DEVICE, PATIENT?S DEVICE WAS SURGICALLY REMOVED IN A SURGICAL PROCEDURE COMMONLY CALLED A REVISION. DURING HIS REVISION SURGERY THE DR NOTED THE NECK HAD FRACTURED AT THE INSERTION OF THE NECK INTO THE STEM. DUE TO THE FAILURE OF HIS PROFEMUR TOTAL HIP SYSTEM, THE DR NEEDED TO REMOVE THE WELL-FIXED FEMORAL STEM WHICH REQUIRED USED OF AN EXTENDED TROCHANTERIC OSTEOTOMY. THIS PROCEDURE REQUIRED AN INDUCED FEMORAL STEM FRACTURE SO AS TO LOOSEN THE COMPONENT FROM THE BONE IN ORDER TO ALLOW EXTRACTION.

  Patient problems: Pain

  MAUDE report 13124742 ↗
• InjuryDec 1, 2021Noise, Audible; Noise, Audible

  ALLEGEDLY, THE PATIENT PRESENTED TO HOSPITAL COMPLAINING RIGHT HIP PAIN AND SQUEAKING. X RAY TAKEN INDICATED WORN OF PROSTHETIC BALL AND SOCKET. SURGEON FOUND DARKENED TISSUE CONSISTENT WITH METALLOSIS. FURTHER INSPECTION REVEALED WHAT APPEARED TO BE A COMPLETE DISSOCIATION OF THE ACETABULAR LINER FROM THE UNDERLYING ACETABULUM. SURGEON ALSO NOTED: SIGNIFICANT WEAR OF THE LOCKING MECHANISM AT THE 10 O´CLOCK POSITION OF THE POLYETHYLENE WAS SHREDDED OFF THE EDGE OF THE POLYETHYLENE. THE FEMORAL HEAD, THE SHELL AND LINER WERE EACH REMOVED. THE ACETABULAR COMPONENT AND LINER WERE REPLACED WITH DEVICES NOT MANUFACTURED BY WRIGHT MEDICAL.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12914017 ↗
• InjuryAug 5, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO COCR CORROSION AT THE PROFEMUR® LONG NECK, DURING THE PROCEDURE DR. (B)(6) FOUND SEVERE METALLOSIS INVOLVING THE ENTIRE SYNOVIUM. COMPONENTS FROM ANOTHER MANUFACTURER: 48MM MEDACTA VERSAFIT ACETABULAR SHELL, 28MM MEDACTA DUAL MOBILITY POLY LINER.

  Patient problems: Toxicity

  MAUDE report 10371206 ↗
• InjuryApr 21, 2020Break; Break

  ALLEGEDLY, CERAMIC HEAD BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983636 ↗