LFIT 6260-9-344Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327032802), received between Oct 15, 2018 and Oct 28, 2025 — classified as 4 injuries.

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

• InjuryOct 28, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: High metal ion levels; Metal Related Pathology

  MAUDE report 23402720 ↗
• InjuryMar 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, TRUNNION WEAR WAS ALSO NOTED. THE STEM, HEAD AND LINER WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21540732 ↗
• InjurySep 7, 2021Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT HAS BEEN REPORTED "CONE WEAR OF THE HIP STEM" UPDATE 20AUG21 - ADDITIONAL INFORMATION FROM THE SURGEON: -REVISION RIGHT HIP TEP VIA DORSAL APPROACH WAS PERFORMED ON (B)(6) 2021. -ANALYSIS OF THE JOINT: METALOSIS, CONE OF THE HIP STEM USED UP, PE INLAY DAMAGED, CUP TRIDENT X3 /58MM FIXED, HEAD COCR 44MM/V40CONE. - REMOVAL OF THE HIP STEM VIA TRANSFEMORAL APPROACH. - THE CONE OF THE FEMORAL STEM WAS USED UP. - THE FEMORAL HEAD IS LUXATED. "HEAD DISASSOCIATION FROM THE FEMORAL STEM."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology

  MAUDE report 12432514 ↗
• InjuryOct 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON REVISED A RIGHT HIP. HE REMOVED A 44 MM LINER AND A 44+8 METAL HEAD AND REPLACED WITH NEW LINER AND CERAMIC HEAD. ITEMS THAT WERE NOT EXPLANTED ARE AS FOLLOWS: 509-02-64G. LOT MKTKRL; 6721-0635, LOT 38447804. UPDATE 19/SEPTEMBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT COMPLAINED OF PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7967461 ↗