Insignia 7000-6602Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327511543), received between Jan 13, 2023 and Jul 23, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT LEFT HIP REVISED DUE TO PERIPROSTHETIC FRACTURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. AN INSIGNIA STEM AND CERAMIC HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, AND 4 DALL-MILES CABLES.

  Patient problems: Bone Fracture(s)

  MAUDE report 22581239 ↗
• InjuryAug 25, 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 FEMORAL PERIPROSTHETIC FRACTURE. A STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH ANOTHER FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 20060823 ↗
• InjuryMay 28, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A LOOSE INSIGNIA STEM; STEM AND HEAD WERE REVISED. THE PATIENT HAD HIS LEFT HIP REVISED FOR PAIN AND LOOSENING OF THE FEMORAL STEM INSIGNIA SIZE 2 HIGH OFFSET.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19403217 ↗
• InjuryJun 6, 2023Use of Device Problem; Use of Device Problem

  MPS PLANNED SIZE 2 INSIGNIA STEM FOR 4.1 THA MAKO CASE. REVIEWED PLAN WITH SURGEON PRIOR TO HIM SCRUBBING IN. WHILE BROACHING WITH SIZE 1, SURGEON WANTED TO SEE A SIZE 1 ON MAKO PLAN, THEN CONTINUED TO BROACH TO A SIZE 2 NOTING IT WAS A BETTER FIT. TRAILED WITH SIZE 2. LANDMARKS CAPTURED, HIP LENGTH LONGER THAN GOAL. SURGEON CALCAR REAMED WITH SIZE 1 BROACH AND THEN DID NOT RETURN TO SIZE 2 BROACH WHILE TRAILING. CONTINUED ON TRAILING WITH SIZE 1 WITHOUT MPS KNOWLEDGE. PRESENTED SIZE 2 INSIGNIA HIGH OFFSET IMPLANT BOX AND HEAD TO SURGEON, READING OUT PARTS AND SIZES. SURGEON LOOKED UP AT BOXES AND ACKNOWLEDGED CORRECT AND TO OPEN BOXES. NO FOLLOWING LANDMARKS WERE CAPTURED TO ATTAIN FINAL LENGTH AND OFFSET. SURGEON CLOSED PATIENT WITHOUT CONCERN. CARD WAS HANDED TO SURGEON CONTAINING FINAL LENGTH AND OFFSET NUMBERS AS WELL AS IMPLANT STICKERS. UPON EXAMINING POST OP XR PRIOR TO PATIENT LEAVING OR, SURGEON DETERMINED PT LEG LENGTH TO BE LONGER THAN GOAL. SURGEON CONTACTED MPS NOTING HE WANTED A SIZE 1 STEM NOT A 2 AND HE WANTS TO OPEN PATIENT UP AGAIN AND SWITCH TO SIZE 1 STEM. PT WAS OPENED AND STEM WAS SWITCHED TO SIZE 1 FROM 2 AND A NEW BIOLOX 36MM +0 HEAD WAS IMPLANTED. UPON FUR

  Patient problems: Insufficient Information

  MAUDE report 17076217 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER INSERTION OF THE STEM IT WAS NOTED THAT THE PATIENT HAD A NONDISPLACED CALCAR FRACTURE. WE EXPOSED THE ENTIRETY OF THE FRACTURE AND IT TRAVELED TO THE LESSER TROCHANTER, BUT NOT INTO IT OR BELOW IT. WE THEN REMOVED THE STEM AND PLACED TWO CABLES, ONE ABOVE THE LESSER TROCHANTER AND ONE BELOW THE LESSER TROCHANTER. THE STEM WAS REINSERTED AND HAD EXCELLENT PRESS-FIT.

  Patient problems: Bone Fracture(s)

  MAUDE report 16155681 ↗