G7® Acetabular System 010000666Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304524255), received between Apr 21, 2021 and Sep 16, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Separation Failure; Separation Failure

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064350 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED ONGOING AND INCREASING PAIN APPROXIMATELY 3 YEARS POST-IMPLANTATION. IT HAS BEEN REPORTED THAT THE PATIENT¿S PAIN WAS TREATED WITH ULTRASOUND GUIDED BLOCKADE AND WAS RESOLVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22892865 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY COMPLETED. SUBSEQUENTLY, PRIOR TO OUTPATIENT DISCHARGE, POST-OPERATIVE ORTHOSTATIC HYPOTENSION AND A RIGHT POSTEROLATERAL HEMATOMA WERE NOTED. THE PATIENT WAS TRANSFERRED FROM THE SURGERY CENTER AND ADMITTED TO A HOSPITAL FACILITY FOR OBSERVATION AND MEDICAL INTERVENTION. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE STUDY HAS SINCE BEEN COMPLETED PER PROTOCOL WITH NO FURTHER COMPLICATIONS OR ALLEGATIONS AGAINST THE DEVICE, ALL INITIAL PRODUCT REMAINS IMPLANTED. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 18924071 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION 14 DAYS POSTOP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 17171923 ↗
• InjurySep 26, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN DATE, PATIENT STARTED TO EXPERIENCE PAIN, DIFFICULTY WALKING AND TROUBLE SLEEPING FOR LONG PERIODS OF TIME. NO PLAN FOR REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Pain; Sleep Dysfunction

  MAUDE report 15484922 ↗
• InjuryAug 24, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP SURGERY. SUBSEQUENTLY, THE TRILOGY SCREW APPEARS TO HAVE SUNK PAST THE CUP¿S SCREW HOLE APPROXIMATELY TWO DAYS LATER. NO REVISION SURGERY HAS BEEN REPORTED TO DATE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 15286493 ↗
• MalfunctionApr 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS DEBRIS IN THE STERILE PACKAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699876 ↗

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-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.