Insignia 7000-5505Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327511604), received between Nov 14, 2022 and Dec 22, 2025 — classified as 4 injuries.

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

• InjuryDec 22, 2025Malposition of Device; Migration; Malposition of Device; Migration

  PATIENT'S RIGHT HIP REVISED DUE TO STEM SUBSIDENCE. THERE WERE NO FRACTURES. PATIENT WAS CONVERTED FROM A HEMI TO A TOTAL HIP WAS DUE TO PAIN. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 23863419 ↗
• InjuryJul 25, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT (MAKO) HIP WAS REVISED DUE TO PAIN AND SUBSIDENCE (REP CONFIRMED THERE WAS NO BONE FRACTURE). SURGEON NOTED AND WAS CONCERNED THAT THERE WAS LITTLE BONE ONGROWTH ON THE STEM INTRA-OPERATIVELY AND WANTS AN INVESTIGATION. THE STEM AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17393304 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMERGENCY RIGHT TOTAL HIP REVISION; STEM WILL MOST LIKELY BE REMOVED. PER OP REPORT DATED (B)(6) 22: PT "SUFFERED A FALL FROM A HEIGHT. SHE LANDED ON HER RIGHT HIP AND HAD IMMEDIATE PAIN AND DISCOMFORT. SHE WAS TAKEN TO AN OUTSIDE HOSPITAL WHERE SHE WAS FOUND TO HAVE A DISPLACED RIGHT HIP PERIPROSTHETIC HIP FRACTURE. SHE WAS TRANSFERRED TO FOR HIGHER LEVEL OF CARE. ORTHOPEDICS WAS CONSULTED, AND I WAS ASKED TO REVIEW HER CASE FOR THE PURPOSES OF SURGICAL FIXATION. SHE WAS INDICATED FOR A REVISION RIGHT HIP REPLACEMENT GIVEN THE RADIOGRAPHIC APPEARANCE OF A LOOSE STEM AND A MULTI PART PERIPROSTHETIC FEMUR FRACTURE.¿

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 15904449 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL HIP ARTHROPLASTY WITH A SLIGHTLY DISPLACED RIGHT GREATER TROCHANTERIC FRACTURE AFTER A FALL DIAGNOSED AT POST OP VISIT ON (B)(6) 2022. PATIENT OPTED FOR CONSERVATIVE MANAGEMENT AND RE-EVALUATION IN 2 WEEKS. PATIENT REPORTS AT FOLLOW UP VISIT ON (B)(6) 2022 HER PAIN HAS INCREASED SLIGHTLY. DIFFICULT TO WALK. SURGEON FEELS ONLY OPTION WOULD BE AN ORIF W/POSSIBLE HEAD AND LINER EXCHANGE. (B)(6) 2022 SURGEON PERFORMS ORIF AND HEAD AND LINER EXCHANGE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 15786479 ↗