Insignia 7000-6606Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327511406), received between Aug 30, 2022 and Sep 25, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  The following information was provided: Patient revised due to periprosthetic fracture. No other information available due to hospital policy.

  Patient problems: Periprosthetic fracture

  MAUDE report 50896024 ↗
• InjuryFeb 25, 2026Loss of Osseointegration; Migration

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT HIP INSIGNIA STEM DUE TO SUBSIDENCE WHICH CAUSED PAIN FOR THE PATIENT. HE REVISED THE LINER FROM A 44 TO A 40 AND REMOVED THE ACETABULAR SCREW. HE REVISED THE STEM TO A COMPETITOR STEM. UPDATE REGARDING REVISED LINER AND SCREW: NO ALLEGATIONS AGAINST THE IMPLANT. HE REMOVED THE SCREW BECAUSE IT WAS NO LONGER NEEDED. HE CHANGED FROM A 44 TO A 40 LINER BECAUSE COMPETITOR DIDN'T HAVE A 44 HEAD OPTION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24443598 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT'S HIP REVISED DUE TO PERIPROSTHETIC FEMORAL FRACTURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Periprosthetic fracture

  MAUDE report 24433782 ↗
• InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration

  SURGEON SUSPECTED A LOOSE FEMORAL COMPONENT, REVISION SURGERY WAS PERFORMED AND THE DIAGNOSIS WAS CONFIRMED. HE PROCEEDED TO REVISE AN INSIGNIA STEM AND PUT IN A RESTORATION MODULAR STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23669978 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "LEFT HIP. PATIENT REVISED DUE TO PERIPROSTHETIC FRACTURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.".

  Patient problems: Bone Fracture(s)

  MAUDE report 22144372 ↗
• InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. DUE TO THE CERAMIC HEAD FRACTURING IN HALF, THE HEAD DISSOCIATED FROM THE STEM. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22012649 ↗
• InjuryJun 12, 2024Material Erosion; Fracture; Material Erosion; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE FOLLOWING WAS NOTED: THE CERAMIC HEAD WAS BROKEN INTO AT LEAST 2 PIECES. THE INSIDE OF THE HEAD SHOWED CONCENTRIC WEAR, AND THE TRUNNION WAS DAMAGED. REVISING SURGEON REPORTED HIS ASSESSMENT: THE SURGEON FOR THE INDEX PROCEDURE (DIFFERENT SURGEON) WASTED A -5 CERAMIC HEAD, AND IMPLANTED A +7.5 CERAMIC HEAD WITHOUT A SLEEVE. REVISING SURGEON BELIEVES THE HEAD WAS NOT FULLY IMPACTED ON THE STEM, LEADING TO MOTION OF THE HEAD ON THE STEM. THE CERAMIC HEAD AND NEUTRAL POLY LINER WERE REVISED TO ANOTHER CERAMIC HEAD AND NEUTRAL ECENTRIC POLY LINER (REASON FOR THE LINER CHANGE WAS THE SURGEON WANTED TO TIGHTEN UP THE CONSTRUCT AND DID NOT WANT TO USE A +7.5 OR +10 HEAD).

  Patient problems: Pain

  MAUDE report 19517457 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A HEAD/STEM DUE TO PERI-PROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19184812 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DIAGNOSIS: RIGHT HIP PAIN. RIGHT HIP REVISION ARTHROPLASTY FEMORAL COMPONENT ONLY WITH OPEN REDUCTION INTERNAL FIXATION. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." A STEM AND HEAD WERE REVISED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15318317 ↗