G7® 110003453Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868462511), received between May 6, 2022 and Feb 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K121874); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE DOING PREVENTATIVE MAINTENANCE ON THE INSERTER, IT WAS FOUND TO BE BROKEN. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293743 ↗
• MalfunctionOct 7, 2024Separation Failure; Damaged Thread; Separation Failure; Damaged Thread

  IT WAS REPORTED THAT WHEN INSERTING THE CUP, THE INSERTER THREADS WERE DEFORMED, AND IT COULD NOT BE REMOVED. THE THREADED SHAFT IN THE INSERTER APPEARS DAMAGED, BUT UNABLE TO CONFIRM AS THE PIECES WERE UNABLE TO BE SEPARATED LATER. ANOTHER CUP WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS A 16-30 MINUTE DELAY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388906 ↗
• MalfunctionJun 13, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530607 ↗
• MalfunctionMay 6, 2022Fracture; Fracture

  IT WAS REPORTED DURING THE SURGERY, THE SURGEON WAS IMPACTING A G7 SHELL AND THE END OF THE G7 OFFSET INSERTER BROKE OFF. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14303658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.

• Z-0007-2023 · Aug 25, 2022 · Open, Classified
  G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.