G7® 010002736Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868413049), received between Sep 13, 2022 and Apr 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE BALL HEX DRIVER WAS STUCK INSIDE THE HANDLE CUP INSERTER. THE SCRUB TECH WAS HITTING THE BALL HEX DRIVER TO DISLODGE IT FROM THE CUP INSERTER AND THE SHAFT BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134574 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED AFTER IMPLANTATION AND WHEN LOOSENING THE SOCKET, THE BALL HEX DRIVER BROKE OFF. THE SHELL COULD NO LONGER BE DETACHED AFTER REPEATED ATTEMPTS FROM THE INSERT HANDLE AND HAD TO BE REMOVED TOGETHER WITH THE PAN. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15408979 ↗

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.