G7® Acetabular System 010000668Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304524279), received between Nov 21, 2022 and Jun 13, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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.

• MalfunctionJun 13, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT THE ACETABULAR IMPLANT WHEN OPENING DURING SURGERY HAD METAL PARTICLES AND A RIPPED BAG SEALING THE IMPLANT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. NO KNOWN CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204868 ↗
• InjuryNov 21, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT 10 MONTHS AFTER A LEFT TOTAL ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO GROIN PAIN, LOOSENING AND MIGRATION OF THE ACETABULAR CUP. THE HEAD, LINER, SHELL AND SCREWS WERE ALL PLACED WITHOUT COMPLICATION. THE STEM WAS STABLE AND REMAINED INTACT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 15832946 ↗

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.