G7 ACETABULAR SCREW 010001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304527485), received between Feb 5, 2020 and Jul 22, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE WEEK POST IMPLANTATION DUE TO PAIN. RADIOGRAPHIC IMAGING DISPLAYED A BONY ACETABULAR FRACTURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Periprosthetic fracture

  MAUDE report 22563649 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION THE PATIENT WAS REVISED DUE TO A FRACTURED ACETABULUM. THE SURGEON STATED THAT ACETABULUM FRACTURE CAUSE IS UNKNOWN BUT MAY HAVE OCCURRED AT THE TIME OF IMPLANTATION AND WENT UNNOTICED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Unequal Limb Length

  MAUDE report 19331282 ↗
• InjuryNov 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENT¿S CUP STARTED TO WEAR AND WAS REVISED. ONE YEAR POST IMPLANTATION, THE PATIENT FELL, AND THE CUP WAS FOUND TO BE LOOSE. THE SURGEON RECOMMENDED A CUSTOM IMPLANT.

  Patient problems: Fall

  MAUDE report 18242031 ↗
• InjuryOct 29, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719158 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670891 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670883 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670881 ↗

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.