Insignia 7000-6605Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327511499), received between Nov 9, 2023 and Sep 22, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Degraded” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported: "Revised a right hip due to periprosthetic femoral fracture. He revised the head and stem to a competitor, and kept the original cup and liner. He was unsure when the fracture had occurred. Rep confirmed that no further information will be released by the hospital or surgeon".

  Patient problems: Bone Fracture(s)

  MAUDE report 50855352 ↗
• InjuryMay 28, 2026Noise, Audible

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SQUEAKING. THE HIP CONSTRUCT HAD A POLY LINER WITH A CERAMIC HEAD, BUT THE SURGEON SUSPECTS THAT THERE IS A POSSIBLE UNSPECIFIED ISSUE INSIDE THE HEAD. THE HEAD AND LINER WERE REVISED TO A NEW POLY LINER WITH METAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Discomfort

  MAUDE report 25314898 ↗
• InjuryDec 19, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. SURGEON REPORTED THAT POST-PRIMARY, STAFF ROTATED THE HIP WHILE MOVING THE PATIENT - THIS ROTATED THE STEM WITHIN THE PATIENT'S FEMUR, AND THE PATIENT SUBSEQUENTLY DISLOCATED THREE TIMES. SURGEON DECIDED TO PERFORM REVISION. THE STEM AND HEAD WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23849215 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT HIP STEM AND HEAD DUE TO PER-PROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 21961093 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. AN INSIGNIA STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A NEW HEAD AND SLEEVE. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND SLEEVE, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 20677006 ↗
• InjuryNov 7, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE HEAD BREAKING INTO SEVERAL PIECES. ALL IMPLANTS WERE REMOVED. REP DOES NOT HAVE ANY ADDITIONAL INFORMATION AT THE TIME OF REPORT. UPDATE: THE CUP WAS NOT REVISED. THE LINER WAS REPLACED. THE STEM WAS REPLACED DUE TO THE TRUNNION BEING DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 20635907 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI-PROSTHETIC FRACTURE - PATIENT FELL. ORIGINAL DATE OF SURGERY (TOTAL HIP) (B)(6) 2024. DATE OF REVISION (RES MOD) (B)(6) 2024. REVISION OF HEAD AND STEM. CUP AND LINER STAYED IN PATIENT.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 20426644 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED, RIGHT SIDE, DUE TO DISLOCATION AND FRACTURE OF THE GREATER TROCHANTER. ALL COMPONENTS WERE REMOVED AND REVISED TO A CEMENTED STEM. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 18489864 ↗
• InjuryDec 20, 2023Osseointegration Problem; Osseointegration Problem

  REVISED A LEFT HIP STEM AND HEAD DUE TO STEM BEING LOOSE. HE WAS ABLE TO REMOVE IT AND REPLACE WITH ONE SIZE LARGER INSIGNIA STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18362403 ↗
• InjuryNov 9, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO GROIN PAIN. SURGEON SUSPECTED IMPINGEMENT AND THE STEM WAS FOUND TO BE IN VARUS. THE PATIENT'S HIP CONSTRUCT WAS REVISED USING A 54 MULTI-HOLE SHELL, MDM METAL LINER WITH ADM/ MDM POLY INSERT, FEMORAL HEAD AND SHORT 115 RESTORATION MODULAR STEM CONSTRUCT. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD.

  Patient problems: Joint Impingement; Pain

  MAUDE report 18098650 ↗